Syncope Clinical Trial
— PATCH-EDOfficial title:
Diagnostic Yield of an Ambulatory Patch Monitor in Emergency Department Syncope Patients Unexplained After Emergency Department Evaluation: A Pilot Study (PATCH-ED)
Verified date | September 2016 |
Source | NHS Lothian |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Syncope is a common Emergency Department (ED) presentation but the underlying diagnosis is
not apparent in 60% of patients after assessment and serious adverse event rate is 7% at one
month with most having acute cardiovascular events, also more likely to be unexplained after
ED assessment. Many cardiovascular events are due to arrhythmia, difficult for clinicians to
diagnose, as examination and Electrocardiogram (ECG) findings may both be normal and symptoms
have resolved by the time the patient gets to the ED. Currently establishing a cardiac
arrhythmia as the cause of syncope rests on correlating the arrhythmia with symptoms using
monitoring devices such as Holter but these all have significant drawbacks. The clinical
challenge in the ED is therefore to identify the moderate and high-risk patients and refer
them for further investigation and monitoring if appropriate. The logistics of arranging
follow up within a timely period of the patient's ED visit is often problematic for a variety
of reasons including availability of timely specialty outpatient appointments, a lack of
consensus of the specialty to whom the syncope patient should be referred (cardiology,
medicine, neurology, general practice) and availability of Holter and other monitoring
devices. For this reason most high and medium risk patients are admitted to hospital.
Previous syncope clinical decision rules have not been well adopted due to their lack of
sensitivity and specificity probably due to the varied and heterogeneous nature of
potentially serious causes. However, the majority of patients with syncope have no serious
underlying pathology and do not require hospitalisation. Rather than continued attempts at
risk stratification of outcome based on presentation, more research is required into how we
can better improve diagnosis and therefore treatment in order to provide improved patient
benefit. We believe that ambulatory patch monitoring will allow better and earlier arrhythmia
detection and plan to assess the ability of a 14-day ambulatory patch to detect serious
arrhythmic outcomes at 90 days.
Status | Completed |
Enrollment | 86 |
Est. completion date | September 13, 2017 |
Est. primary completion date | June 13, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: - Patients aged 16 years or over presenting within 6 hours of an episode of syncope and whose syncope remains unexplained after ED assessment. Syncope will be defined as a transient loss of consciousness (TLOC) with inability to maintain postural tone and immediate complete spontaneous recovery without medical intervention (to preexisting mental status and neurologic function) Exclusion Criteria: - Obvious underlying cause after ED assessment, - Alcohol or illicit drugs as presumptive cause of TLOC [24], - Epileptic seizure as presumptive cause of TLOC (seizure activity with a >15 min witness reported post-ictal phase) [24], - Stroke / transient ischemic attack as presumptive cause of TLOC [24], - Head trauma followed by TLOC [24], - Hypoglycemia as presumptive cause of TLOC [24], - No consent i.e. patient lacking capacity, - Previous recruitment into the study, - Patient in custody or prison. Obvious underlying causes will be defined as: - Clinical history of vasovagal syncope i.e. pre-syncope symptoms and low-risk patient according to current ESC guidelines [14], - Arrhythmia on ED ECG thought to have caused syncope, - Arrhythmia on pre-hospital ECG causing syncope, - Pulmonary embolism (PE) diagnosed on Computed Tomography Pulmonary Angiography (CTPA; or equivalent e.g. symptoms of PE plus positive leg ultrasound scan/ventilation-perfusion scan/echo), - Postural hypotension (postural drop >20 mmHg in ED with symptoms during test and suggestive history), - Myocardial Infarction [25], - CT brain or clinical signs/symptoms in ED showing cerebrovascular accident or subarachnoid haemorrhage, - Evidence of haemorrhage in ED thought to have caused syncope, - Other obvious cause of syncope apparent in ED. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Infirmary of Edinburgh | Edinburgh | Midlothian |
Lead Sponsor | Collaborator |
---|---|
NHS Lothian |
United Kingdom,
Barrett PM, Komatireddy R, Haaser S, Topol S, Sheard J, Encinas J, Fought AJ, Topol EJ. Comparison of 24-hour Holter monitoring with 14-day novel adhesive patch electrocardiographic monitoring. Am J Med. 2014 Jan;127(1):95.e11-7. doi: 10.1016/j.amjmed.2013.10.003. Epub 2013 Oct 15. — View Citation
Bass EB, Curtiss EI, Arena VC, Hanusa BH, Cecchetti A, Karpf M, Kapoor WN. The duration of Holter monitoring in patients with syncope. Is 24 hours enough? Arch Intern Med. 1990 May;150(5):1073-8. — View Citation
Camm CF, Tichnell C, James CA, Murray B, Porterfield F, Te Riele AS, Tandri H, Calkins H. Premature ventricular contraction variability in arrhythmogenic right ventricular dysplasia/cardiomyopathy. J Cardiovasc Electrophysiol. 2015 Jan;26(1):53-7. doi: 10.1111/jce.12544. Epub 2014 Oct 27. — View Citation
Cheung CC, Kerr CR, Krahn AD. Comparing 14-day adhesive patch with 24-h Holter monitoring. Future Cardiol. 2014 May;10(3):319-22. doi: 10.2217/fca.14.24. — View Citation
Colivicchi F, Ammirati F, Melina D, Guido V, Imperoli G, Santini M; OESIL (Osservatorio Epidemiologico sulla Sincope nel Lazio) Study Investigators. Development and prospective validation of a risk stratification system for patients with syncope in the emergency department: the OESIL risk score. Eur Heart J. 2003 May;24(9):811-9. — View Citation
Costantino G, Perego F, Dipaola F, Borella M, Galli A, Cantoni G, Dell'Orto S, Dassi S, Filardo N, Duca PG, Montano N, Furlan R; STePS Investigators. Short- and long-term prognosis of syncope, risk factors, and role of hospital admission: results from the STePS (Short-Term Prognosis of Syncope) study. J Am Coll Cardiol. 2008 Jan 22;51(3):276-83. doi: 10.1016/j.jacc.2007.08.059. — View Citation
Del Rosso A, Ungar A, Maggi R, Giada F, Petix NR, De Santo T, Menozzi C, Brignole M. Clinical predictors of cardiac syncope at initial evaluation in patients referred urgently to a general hospital: the EGSYS score. Heart. 2008 Dec;94(12):1620-6. doi: 10.1136/hrt.2008.143123. Epub 2008 Jun 2. — View Citation
Martin TP, Hanusa BH, Kapoor WN. Risk stratification of patients with syncope. Ann Emerg Med. 1997 Apr;29(4):459-66. — View Citation
Oh JH, Hanusa BH, Kapoor WN. Do symptoms predict cardiac arrhythmias and mortality in patients with syncope? Arch Intern Med. 1999 Feb 22;159(4):375-80. — View Citation
Quinn J, McDermott D, Stiell I, Kohn M, Wells G. Prospective validation of the San Francisco Syncope Rule to predict patients with serious outcomes. Ann Emerg Med. 2006 May;47(5):448-54. Epub 2006 Jan 18. — View Citation
Quinn JV, Stiell IG, McDermott DA, Sellers KL, Kohn MA, Wells GA. Derivation of the San Francisco Syncope Rule to predict patients with short-term serious outcomes. Ann Emerg Med. 2004 Feb;43(2):224-32. — View Citation
Reed MJ, Henderson SS, Newby DE, Gray AJ. One-year prognosis after syncope and the failure of the ROSE decision instrument to predict one-year adverse events. Ann Emerg Med. 2011 Sep;58(3):250-6. doi: 10.1016/j.annemergmed.2010.12.021. Epub 2011 Feb 2. — View Citation
Reed MJ, Newby DE, Coull AJ, Prescott RJ, Jacques KG, Gray AJ. The ROSE (risk stratification of syncope in the emergency department) study. J Am Coll Cardiol. 2010 Feb 23;55(8):713-21. doi: 10.1016/j.jacc.2009.09.049. — View Citation
Rosenberg MA, Samuel M, Thosani A, Zimetbaum PJ. Use of a noninvasive continuous monitoring device in the management of atrial fibrillation: a pilot study. Pacing Clin Electrophysiol. 2013 Mar;36(3):328-33. doi: 10.1111/pace.12053. Epub 2012 Dec 13. — View Citation
Sarasin FP, Hanusa BH, Perneger T, Louis-Simonet M, Rajeswaran A, Kapoor WN. A risk score to predict arrhythmias in patients with unexplained syncope. Acad Emerg Med. 2003 Dec;10(12):1312-7. — View Citation
Schreiber D, Sattar A, Drigalla D, Higgins S. Ambulatory cardiac monitoring for discharged emergency department patients with possible cardiac arrhythmias. West J Emerg Med. 2014 Mar;15(2):194-8. doi: 10.5811/westjem.2013.11.18973. — View Citation
Task Force for the Diagnosis and Management of Syncope; European Society of Cardiology (ESC); European Heart Rhythm Association (EHRA); Heart Failure Association (HFA); Heart Rhythm Society (HRS), Moya A, Sutton R, Ammirati F, Blanc JJ, Brignole M, Dahm JB, Deharo JC, Gajek J, Gjesdal K, Krahn A, Massin M, Pepi M, Pezawas T, Ruiz Granell R, Sarasin F, Ungar A, van Dijk JG, Walma EP, Wieling W. Guidelines for the diagnosis and management of syncope (version 2009). Eur Heart J. 2009 Nov;30(21):2631-71. doi: 10.1093/eurheartj/ehp298. Epub 2009 Aug 27. — View Citation
Tattersall LC, Reed MJ. The inpatient management of syncope. Emerg Med J. 2010 Nov;27(11):870-2. doi: 10.1136/emj.2010.092924. Epub 2010 Aug 3. — View Citation
Tung CE, Su D, Turakhia MP, Lansberg MG. Diagnostic Yield of Extended Cardiac Patch Monitoring in Patients with Stroke or TIA. Front Neurol. 2015 Jan 12;5:266. doi: 10.3389/fneur.2014.00266. eCollection 2014. — View Citation
Turakhia MP, Hoang DD, Zimetbaum P, Miller JD, Froelicher VF, Kumar UN, Xu X, Yang F, Heidenreich PA. Diagnostic utility of a novel leadless arrhythmia monitoring device. Am J Cardiol. 2013 Aug 15;112(4):520-4. doi: 10.1016/j.amjcard.2013.04.017. Epub 2013 May 11. — View Citation
* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Ambulatory Patch Monitor Participants Having Significant Symptomatic Arrhythmia | Significant arrhythmia will be defined as: Non-symptomatic ventricular tachycardia < 30 seconds, Symptomatic sinus bradycardia < 60 beats/minute (but >40 or less than 30 seconds), Asymptomatic sinus bradycardia < 40 beats/minute, Sick sinus syndrome with alternating sinus bradycardia and tachycardia, Sinus pause > 3 seconds (but less than 6 seconds), Symptomatic Mobitz type I atrioventricular heart block, Junctional/idioventricular rhythm, Symptomatic supraventricular tachycardia with rate > 100/minute, Symptomatic atrial flutter/fibrillation with ventricular rate >100/min, Symptomatic atrial flutter/fibrillation with ventricular rate <60/min Arrhythmias will also be defined as symptomatic (i.e. concurrent light-headedness/dizziness, syncope/presyncope with arrhythmia) or asymptomatic. |
90 days | |
Secondary | Median Time to Detection of Significant Symptomatic Arrhythmia | Median time to detection of significant symptomatic arrhythmia by ambulatory patch monitor | 90 days | |
Secondary | Number of Participants With Arrhythmia | Prevalence of arrhythmia including serious significant arrhythmia, significant arrhythmia and symptomatic arrhythmia in ED syncope patients unexplained after ED evaluation. | 90 days | |
Secondary | Number of Participants Who Agreed or Strongly Agreed That the Patch Monitor Was Easy to Use. | Number of participants who agreed or strongly agreed that the patch monitor was easy to use. Patient patch satisfaction (postal questionnaire). | 90 days | |
Secondary | Median Device Wear Time | Patch compliance described by median device wear time | 14 days | |
Secondary | Number of Participants With Significant Arrhythmia Requiring Referral. | Number of participants with significant underlying arrhythmic pathology on ambulatory patch monitoring requiring referral. | 90 days | |
Secondary | Number of Participants With All Cause Serious Outcome | All cause serious outcome will be a composite of: All cause death, Major adverse cardiac events [MACE] Myocardial infarction [25], Significant arrhythmia [25], Significant Structural Heart Disease [23], Positive Electrophysiology Study Findings [25] Permanent pacemaker or defibrillator placement, Coronary artery bypass graft or coronary artery stent, Cardiac valve surgery, Elective cardioversion in the absence of objective evidence that tachyarrhythmia is responsible for the syncope, Balloon-pump insertion, Heart transplant, Initiation of anti-arrhythmia medical therapy, Ventricular assist device |
90 days |
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