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"Grubb, Neil"
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Multi-centre randomised controlled trial of a smart phone-based event recorder alongside standard care versus standard care for patients presenting to the Emergency Department with palpitations and pre-syncope - the IPED (Investigation of Palpitations in the ED) study: study protocol for a randomised controlled trial
by
Grant, Alison
,
Reed, Matthew J.
,
Grubb, Neil R.
in
Ambulatory electrocardiography monitoring
,
Arrhythmia
,
Biomedicine
2018
Background
Palpitations and pre-syncope are together responsible for 300,000 annual Emergency Department (ED) attendances in the United Kingdom (UK). Diagnosis of the underlying rhythm is difficult as many patients are fully recovered on ED arrival; and examination and presenting electrocardiogram (ECG) are commonly normal. The only way to establish the underlying heart rhythm is to capture an ECG during symptoms. Recent technology advances have led to several novel ECG monitoring devices appearing on the market. This trial aims to compare the symptomatic rhythm detection rate at 90 days of one such smart phone-based event recorder (AliveCor Heart Monitor and AliveECG) with standard care for participants presenting to the ED with palpitations and pre-syncope and no obvious cause in the ED.
Methods/Design
This is a multi-centre hospital ED / Acute Medical Unit (AMU) open label, randomised controlled trial. Participants will be recruited in 10 tertiary and district general hospitals in the UK. Participants aged ≥ 16 years presenting with an episode of palpitations or pre-syncope with no obvious cause and whose underlying ECG rhythm during these episodes remains undiagnosed after clinical assessment will be included. Participants will be randomised to either: (1) the intervention arm, standard care plus the use of a smart phone-based event recorder; or (2) the control arm, standard care. Primary endpoint will be symptomatic rhythm detection rate at 90 days. A number of secondary clinical, process and cost-effectiveness endpoints will be collected and analysed. Analysis will be on an intention-to-treat basis.
Discussion
The Investigation of Palpitations in the ED (IPED) study aims to recruit 242 participants across 10 hospital sites. It will be the first study to investigate the ability of a smart phone-based event recorder to detect symptomatic cardiac rhythms compared to standard care for ED patients with palpitations and pre-syncope with no obvious cause in the ED. This smart phone event recorder will allow ED patients who have presented with palpitations or pre-syncope to record their ECG tracing if they have a further episode and may increase the rate of underlying rhythm diagnosis.
Trial registration
ClinicalTrials.gov,
NCT02783898
. Registered on 26 May 2016.
Journal Article
Diagnostic yield of an ambulatory patch monitor in patients with unexplained syncope after initial evaluation in the emergency department: the PATCH-ED study
by
Weir, Christopher J
,
Gray, Alasdair J
,
Grubb, Neil R
in
Blood pressure
,
Cardiac arrhythmia
,
Diagnostic tests
2018
ObjectivesDiagnosing underlying arrhythmia in ED syncope patients remains problematic. This study investigates diagnostic yield, event prevalence, patient satisfaction and compliance, and influence on resource utilisation of an ambulatory patch monitor in unexplained ED syncope patients.MethodsProspective pilot study conducted in a single tertiary ED in Scotland between 17 November 2015 and 16 June 2017 with a historical unmatched comparator group. Patients 16 years or over presenting within 6 hours of unexplained syncope were fitted in the ED with an ambulatory patch ECG recorder (Zio XT monitor), which continuously records a single-lead ECG for up to 14 days. Patients with an obvious underlying cause were excluded. An unmatched historical group of 603 syncope patients with no obvious diagnosis in ED, recruited to a prior cohort study (2007–2008), were used as a comparator. Primary endpoint was symptomatic significant arrhythmia at 90-day follow-up.ResultsDuring the prospective study period, 86 patients were recruited. 90-day diagnostic yield for symptomatic significant arrhythmia was 10.5% (95% CI 4.0 to 16.9; 9 of 86) versus 2.0% (95% CI 0.9 to 3.1; 12 of 603) in the comparator group. 24 patients (27.9%) had a significant arrhythmia (five serious); 26 patients (30.2%) had serious outcomes (major adverse cardiac event and/or death). Blinded patch report review suggested the patch would significantly reduce requirement for standard outpatient ambulatory ECG monitoring. 56 of 76 returned patches had a diagnostic finding within±45 s of a triggered/diary event (73.7% diagnostic utility; 95% CI 63.7 to 83.6); 34 of 56 (61%) for sinus rhythm or ectopic beats only.ConclusionsRoutine, early ambulatory ECG monitoring in ED patients with unexplained syncope is probably warranted. A large-scale trial comparing this approach to standard care with cost-effectiveness and safety analysis is now required.Trial registrationNCT02683174.
Journal Article
Multicentre open label randomised controlled trial of immediate enhanced ambulatory ECG monitoring versus standard monitoring in acute unexplained syncope patients: the ASPIRED study
by
Goodacre, Steve
,
Dinsmore, Lynn
,
Weir, Christopher J
in
ACCIDENT & EMERGENCY MEDICINE
,
Adult cardiology
,
Arrhythmias, Cardiac - diagnosis
2023
IntroductionDiagnosing underlying arrhythmia in emergency department (ED) syncope patients is difficult. There is a evidence that diagnostic yield for detecting underlying arrhythmia is highest when cardiac monitoring devices are applied early, ideally at the index visit. This strategy has the potential to change current syncope management from low diagnostic yield Holter to higher yield ambulatory monitoring, reduce episodes of syncope, reduce risk of recurrence and its potential serious consequences, reduce hospital admissions, reduce overall health costs and increase quality of life by allowing earlier diagnosis, treatment and exclusion of clinically important arrhythmias.Methods and analysesThis is a UK open prospective parallel group multicentre randomised controlled trial of an immediate 14-day ambulatory patch heart monitor vs standard care in 2234 patients presenting acutely with unexplained syncope. Our patient focused primary endpoint will be number of episodes of syncope at 1 year. Health economic evaluation will estimate the incremental cost per syncope episode avoided and quality-adjusted life year gained.Ethics and disseminationInformed consent for participation will be sought. The ASPIRED trial received a favourable ethical opinion from South East Scotland Research Ethics Committee 01 (21/SS/0073). Results will be disseminated via scientific publication, lay summary and visual abstract.Trial registration numberISRCTN 10278811.
Journal Article
Complications and prognosis of patients undergoing apical or septal right ventricular pacing
by
Lang, Chris CE
,
Wang, Kelvin
,
Grubb, Neil R
in
Angina pectoris
,
apical pacing
,
Cardiac function
2019
ObjectivesOptimal right ventricular lead placement remains controversial. Large studies investigating the safety and long-term prognosis of apical and septal right ventricular lead placement have been lacking.MethodsConsecutive patients undergoing pacemaker insertion for high-degree atrioventricular block at Edinburgh Heart Centre were investigated. Periprocedural 30-day complications were defined (infection/bleeding/pneumothorax/tamponade/lead displacement). Long-term clinical outcomes were obtained from the General Register of Scotland and electronic medical records. The primary endpoint was a composite of all-cause mortality, new heart failure, hospitalisation for a major cardiovascular event, as per the CArdiac REsynchronization in Heart Failure trial. Secondary endpoints were all-cause mortality, new heart failure and their composite.Results820 patients were included, 204 (25%) paced from the septum and 616 (75%) from the apex. All baseline variables were similar with the exception of age (septal: 73.2±1.1 vs apical: 76.9±0.5 years, p<0.001). Procedure duration (58±23 vs 55±25 min, p=0.3), complication rates (18 (8.8) vs 46 (7.5)%, p=0.5) and postimplant QRS duration (152 (23) vs 154 (27) ms, p=0.4) were similar. After 1041 days (IQR 564), 278 patients met the primary endpoint, with no difference between the septal and apical groups in unadjusted (HR 0.86 (95% CIs 0.64 to 1.15)) or multivariable analysis correcting for age, gender and comorbidity (HR 0.97 (95% CI 0.72 to 1.30)). Similarly, no differences were observed in the secondary endpoints.ConclusionsThis large real-world cohort of patients undergoing right ventricular lead placement in the septum or apex demonstrated no difference in procedural complications nor long-term clinical outcomes. Both pacing strategies appear reasonable in routine practice.
Journal Article
Prediction of cognitive dysfunction after resuscitation from out-of-hospital cardiac arrest using serum neuron-specific enolase and protein S-100
2007
Background:More than 50% of patients initially resuscitated from out-of-hospital cardiac arrest die in hospital.Objective:To investigate the prognostic value of serum protein S-100 and neuron-specific enolase (NSE) concentrations for predicting (a) memory impairment at discharge; (b) in-hospital death, after resuscitation from out-of-hospital cardiac arrest.Methods:In a prospective study of 143 consecutive survivors of out-of-hospital cardiac arrest, serum samples were obtained within 12, 24–48 and 72–96 hours after the event. S-100 and NSE concentrations were measured. Pre-discharge cognitive assessment of patients (n = 49) was obtained by the Rivermead Behavioural Memory Test (RBMT). The relationship between biochemical brain marker concentrations and RBMT scores, and between marker concentrations and the risk of in-hospital death was examined.Results:A moderate negative relationship was found between S-100 concentration and memory test score, at all time points. The relationship between NSE and memory test scores was weaker. An S-100 concentration >0.29 μg/l at time B predicted moderate to severe memory impairment with absolute specificity (42.8% sensitivity). S-100 remained an independent predictor of memory function after adjustment for clinical variables and cardiac arrest timing indices. NSE and S-100 concentrations were greater in patients who died than in those who survived, at all time points. Both NSE and S-100 remained predictors of in-hospital death after adjustment for clinical variables and cardiac arrest timing indices. The threshold concentrations yielding 100% specificity for in-hospital death were S-100: 1.20 μg/l (sensitivity 44.8%); NSE 71.0 μg/l (sensitivity 14.0%).Conclusions:Estimation of serum S-100 concentration after out-of-hospital cardiac arrest can be used to identify patients at risk of significant cognitive impairment at discharge. Serum S-100 and NSE concentrations measured 24–48 hours after cardiac arrest provide useful additional information.
Journal Article
Brain natriuretic peptide and high-sensitivity Troponin at 3 hours post emergency department attendance with unexplained syncope predict 90 day outcome
by
Weir, Christopher J.
,
Reed, Matthew James
,
Grubb, Neil R.
in
Ambulatory electrocardiography monitoring
,
Cardiac arrhythmia
,
Cardiac arrhythmias
2018
To investigate if Brain Natriuretic Peptide (BNP) and highsensitivity troponin I predict significant arrhythmia, symptomatic significant arrhythmia and 90-day death and/or Major Adverse Cardiac Event in Emergency Department (ED) unexplained syncope patients investigated with a 14-day ambulatory electrocardiogram (ECG) recorder. Single-centre, prospective, cohort study. Patients 16 years or over presenting within 6 hours of an episode of unexplained syncope were fitted with an ambulatory ECG recorder (Zio® XT monitor) and had high-sensitivity troponin I and BNP measured on ED admission and 3 hours later. Between 17/11/2015 and 13/06/2017, 86 patients were recruited. 24 had significant arrhythmia, 9 symptomatic significant arrhythmia and 26 patients had death and/or Major adverse cardiac events by 90 days. BNP at admission, three hours and change in BNP and high-sensitivity troponin I at three hours were associated with significant arrhythmia and serious outcome. BNP>20pg/mL and/or high-sensitivity troponin I above the 99% sex specific centile (M>34ng/L, F>16ng/L) at 3 hours had a sensitivity of 100% (21/21; 95% CI 81%-100%) and specificity of 43% (16/37; 28%-60%) for significant arrhythmia and a sensitivity of 100% (22/22; 95% CI 82%- 100%) and specificity of 44% (16/36; 28%-62%) for serious outcome both at 90 days. The combination of BNP and high-sensitivity troponin I at 3 hours shows promise as a potential predictive marker for serious arrhythmia and serious outcome at 90 days and deserves further exploration as a rule out test to enable safe discharge of patients from the ED who are at low risk of having cardiac syncope and subsequent adverse events.
Journal Article
CT coronary angiography in patients with suspected angina due to coronary heart disease (SCOT-HEART): an open-label, parallel-group, multicentre trial
The benefit of CT coronary angiography (CTCA) in patients presenting with stable chest pain has not been systematically studied. We aimed to assess the effect of CTCA on the diagnosis, management, and outcome of patients referred to the cardiology clinic with suspected angina due to coronary heart disease.
In this prospective open-label, parallel-group, multicentre trial, we recruited patients aged 18–75 years referred for the assessment of suspected angina due to coronary heart disease from 12 cardiology chest pain clinics across Scotland. We randomly assigned (1:1) participants to standard care plus CTCA or standard care alone. Randomisation was done with a web-based service to ensure allocation concealment. The primary endpoint was certainty of the diagnosis of angina secondary to coronary heart disease at 6 weeks. All analyses were intention to treat, and patients were analysed in the group they were allocated to, irrespective of compliance with scanning. This study is registered with ClinicalTrials.gov, number NCT01149590.
Between Nov 18, 2010, and Sept 24, 2014, we randomly assigned 4146 (42%) of 9849 patients who had been referred for assessment of suspected angina due to coronary heart disease. 47% of participants had a baseline clinic diagnosis of coronary heart disease and 36% had angina due to coronary heart disease. At 6 weeks, CTCA reclassified the diagnosis of coronary heart disease in 558 (27%) patients and the diagnosis of angina due to coronary heart disease in 481 (23%) patients (standard care 22 [1%] and 23 [1%]; p<0·0001). Although both the certainty (relative risk [RR] 2·56, 95% CI 2·33–2·79; p<0·0001) and frequency of coronary heart disease increased (1·09, 1·02–1·17; p=0·0172), the certainty increased (1·79, 1·62–1·96; p<0·0001) and frequency seemed to decrease (0·93, 0·85–1·02; p=0·1289) for the diagnosis of angina due to coronary heart disease. This changed planned investigations (15% vs 1%; p<0·0001) and treatments (23% vs 5%; p<0·0001) but did not affect 6-week symptom severity or subsequent admittances to hospital for chest pain. After 1·7 years, CTCA was associated with a 38% reduction in fatal and non-fatal myocardial infarction (26 vs 42, HR 0·62, 95% CI 0·38–1·01; p=0·0527), but this was not significant.
In patients with suspected angina due to coronary heart disease, CTCA clarifies the diagnosis, enables targeting of interventions, and might reduce the future risk of myocardial infarction.
The Chief Scientist Office of the Scottish Government Health and Social Care Directorates funded the trial with supplementary awards from Edinburgh and Lothian's Health Foundation Trust and the Heart Diseases Research Fund.
Journal Article
Coronary CT angiography-guided management of patients with stable chest pain: 10-year outcomes from the SCOT-HEART randomised controlled trial in Scotland
2025
The Scottish Computed Tomography of the Heart (SCOT-HEART) trial demonstrated that management guided by coronary CT angiography (CCTA) improved the diagnosis, management, and outcome of patients with stable chest pain. We aimed to assess whether CCTA-guided care results in sustained long-term improvements in management and outcomes.
SCOT-HEART was an open-label, multicentre, parallel group trial for which patients were recruited from 12 outpatient cardiology chest pain clinics across Scotland. Eligible patients were aged 18–75 years with symptoms of suspected stable angina due to coronary heart disease. Patients were randomly assigned (1:1) to standard of care plus CCTA or standard of care alone. In this prespecified 10-year analysis, prescribing data, coronary procedural interventions, and clinical outcomes were obtained through record linkage from national registries. The primary outcome was coronary heart disease death or non-fatal myocardial infarction on an intention-to-treat basis. This trial is registered at ClinicalTrials.gov (NCT01149590) and is complete.
Between Nov 18, 2010, and Sept 24, 2014, 4146 patients were recruited (mean age 57 years [SD 10], 2325 [56·1%] male, 1821 [43·9%] female), with 2073 randomly assigned to standard care and CCTA and 2073 to standard care alone. After a median of 10·0 years (IQR 9·3–11·0), coronary heart disease death or non-fatal myocardial infarction was less frequent in the CCTA group compared with the standard care group (137 [6·6%] vs 171 [8·2%]; hazard ratio [HR] 0·79 [95% CI 0·63–0·99], p=0·044). Rates of all-cause, cardiovascular, and coronary heart disease death, and non-fatal stroke, were similar between the groups (p>0·05 for all), but non-fatal myocardial infarctions (90 [4·3%] vs 124 [6·0%]; HR 0·72 [0·55–0·94], p=0·017) and major adverse cardiovascular events (172 [8·3%] vs 214 [10·3%]; HR 0·80 [0·65–0·97], p=0·026) were less frequent in the CCTA group. Rates of coronary revascularisation procedures were similar (315 [15·2%] vs 318 [15·3%]; HR 1·00 [0·86–1·17], p=0·99) but preventive therapy prescribing remained more frequent in the CCTA group (831 [55·9%] of 1486 vs 728 [49·0%] of 1485 patients with available data; odds ratio 1·17 [95% CI 1·01–1·36], p=0·034).
After 10 years, CCTA-guided management of patients with stable chest pain was associated with a sustained reduction in coronary heart disease death or non-fatal myocardial infarction. Identification of coronary atherosclerosis by CCTA improves long-term cardiovascular disease prevention in patients with stable chest pain.
The Chief Scientist Office of the Scottish Government Health and Social Care Directorates, Edinburgh and Lothian's Health Foundation Trust, British Heart Foundation, and Heart Diseases Research Fund.
Journal Article
An Algorithm for the Detection of Individual Breaths from the Pulse Oximeter Waveform
by
Watson, James N.
,
Leonard, Paul
,
Grubb, Neil R.
in
Algorithms
,
Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy
,
Biological and medical sciences
2004
To determine if wavelet analysis techniques can be used to reliably identify individual breaths from the photoplethysmogram (PPG).
Photoplethysmograms were obtained from 22 healthy adult volunteers timing their respiration rate in synchronisation with a metronome. A secondary timing signal was obtained by asking the volunteers to actuate a small push button switch, held in their right hand, in synchronisation with their respiration. Each PPG was analyzed using primary wavelet decomposition and two new, related, secondary decompositions to determine the accuracy of individual breath detection.
The optimal breath capture was obtained by manually polling the three techniques, allowing detection of 466 out of the 472 breaths studied; a detection rate of 98.7% with no false positive breaths detected.
Our technique allows the accurate capture of individual breaths from the photoplethysmogram, and leads the way for developing a simple non-invasive combined respiration and saturation monitor.
Journal Article
A Fully Automated Algorithm for the Determination of Respiratory Rate from the Photoplethysmogram
by
Watson, James N.
,
Grubb, Neil R.
,
Addison, Paul S.
in
Adult
,
Algorithms
,
Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy
2006
To determine if an automatic algorithm using wavelet analysis techniques can be used to reliably determine respiratory rate from the photoplethysmogram (PPG).
Photoplethysmograms were obtained from 12 spontaneously breathing healthy adult volunteers. Three related wavelet transforms were automatically polled to obtain a measure of respiratory rate. This was compared with a secondary timing signal obtained by asking the volunteers to actuate a small push button switch, held in their right hand, in synchronisation with their respiration. In addition, individual breaths were resolved using the wavelet-method to identify the source of any discrepancies.
Volunteer respiratory rates varied from 6.56 to 18.89 breaths per minute. Through training of the algorithm it was possible to determine a respiratory rate for all 12 traces acquired during the study. The maximum error between the PPG derived rates and the manually determined rate was found to be 7.9%.
Our technique allows the accurate measurement of respiratory rate from the photoplethysmogram, and leads the way for developing a simple non-invasive combined respiration and saturation monitor.
Journal Article