- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05532787
Comparison of Accelerated Diagnostic Pathways for Acute Chest Pain in Emergency Departments in the United Arab Emirates
Comparison of Accelerated Diagnostic Pathways for Acute Chest Pain (EDACS & HEART Pathway) in Emergency Departments of the United Arab Emirates: A Multi-Center Prospective Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim is to evaluate the safety, efficacy and economic feasibility of applying the EDACS and HEART pathways into existing EDs in the emirate of Abu Dhabi, UAE as well as to validate the sensitivity and NPV of these pathways given the United Arab Emirate's diverse population.
Over a period of 12 months, ED Physicians at four institutions will collect and retrieve data from their encounters with patients presenting with chest pain. Participants will be recruited from the EDs of four hospitals in the SEHA health network including Zayed Military Hospital, Tawam Hospital, Shaikh Shakhbout Medical City and Cleveland Clinic Abu Dhabi. Our study will include all eligible patients aged 18 years and above presenting acutely from the community to the ED with the chief complaint of chest pain or cardiac symptoms suggestive of ACS as defined by the American Heart Association with at least one troponin ordered, without evidence of ST-segment elevation myocardial infarction on ECG will be included. Chest pain will be defined as anterior chest pain, any discomfort located on the anterior thorax between the suprasternal notch and the xiphoid process, using the posterior axillary line as the border between the anterior and posterior thorax. In accordance with American Heart Association case definitions, other suggestive cardiac symptoms include the presence of epigastric, neck, jaw, or arm pain, discomfort or pressure without an apparent noncardiac source will also be included.
Patients that will be excluded are patients younger than 18 years or older than 90 years of age, patients with acute ST-segment elevation on the initial ECG in at least 2 contiguous leads, Hemodynamic instability (pulse rate persistently greater than 100 or less than 50 beats/min or systolic blood pressure persistently below 90 mm Hg), clear traumatic or radiologically evident of non-cardiac etiology, terminal non-cardiac illness, pregnancy or anticipated difficulty in communication or follow up such as any patient with no fixed address or telephone number in the UAE, previous enrollment and incapability or unwillingness for consent.
Data elements for the HEART Pathway and EDACS-ADP assessments will be entered prospectively by physicians into an Electronic Health Records (EHR)-based clinical decision support tool as well as alternatively a Data Collection Sheet will also be provided. EDACS-ADP and HEART pathways scores will be retrospectively calculated by research investigators not directly involved in patient care and will be logged in the Data collection sheet for each patient. After 30 days, patients will be reviewed for MACE defined as death, cardiac arrest, emergency revascularization procedure (coronary artery bypass grafting, stent placement, or other percutaneous coronary intervention), cardiogenic shock, ventricular arrhythmia needing intervention, high-degree atrioventricular block needing intervention, and acute myocardial infarction. All patients will undergo follow up by all three of the following approaches: telephone contact, review of patient hospital notes, and national death and health events search.
Data will be collected for a period of approximately 12 months from September onward, with a target sample size of 800 patients. Patients will be informed of the use of their de-identified data for research purposes and consented for its use. Informed written consent will be obtained from all subjects. All patient data will be anonymous and given a unique research ID. The data will be stored in an encrypted file on a secure computer, and all patient data will be protected. Extracted data from collection sheets will be stored on an encrypted hard drive, accessible only to investigators listed (as in the IRB form) and analyzed using the SPSS software.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Farya Rehman, MBBS
- Phone Number: +971547497722
- Email: faryarehman@gmail.com
Study Contact Backup
- Name: Rauda Al Nuami, MBBS
- Phone Number: +971505639877
- Email: dr.rauda@hotmail.com
Study Locations
-
-
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Abu Dhabi, United Arab Emirates, 00000
- Not yet recruiting
- Cleveland Clinic Abu Dhabi
-
Contact:
- Shaza Karrar, MBBS
- Phone Number: +971509808108
- Email: shaza.karrar114@gmail.com
-
Sub-Investigator:
- Shaza Karrar, MBBS
-
Principal Investigator:
- Carlos Torres, MD
-
Abu Dhabi, United Arab Emirates, 00000
- Recruiting
- Sheikh Khalifa Medical City
-
Contact:
- Maryam Siddiqi, MBBS
- Phone Number: +971501191178
- Email: masiddiqi@seha.ae
-
Principal Investigator:
- Maryam Siddiqi, MBBS
-
Abu Dhabi, United Arab Emirates, 00000
- Recruiting
- Sheikh Shakhbout Medical City
-
Contact:
- Aya Doudin, MBBS
- Phone Number: +971503951593
- Email: ayadodin@yahoo.com
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Principal Investigator:
- Aya Doudin, MBBS
-
Abu Dhabi, United Arab Emirates, 00000
- Recruiting
- Zayed Military Hospital
-
Contact:
- Rauda Al Nuami, MBBS
- Phone Number: +971505639877
- Email: dr.rauda@gmail.com
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Contact:
- Ruqaya Al Afeefi, MBBS
- Phone Number: +971544484724
- Email: ruq.alafeefi@gmail.com
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Principal Investigator:
- Rauda Al Nuami, MBBS
-
Sub-Investigator:
- Ruqaya Al Afeefi, MBBS
-
Al Ain, United Arab Emirates, 00000
- Recruiting
- Tawam Hospital
-
Contact:
- Amani Al Abdouli, MBBS
- Phone Number: +971592662287
- Email: alabdouli.aman12@gmail.com
-
Principal Investigator:
- Amani Al Abdouli, MBBS
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Greater than 18 year old with a chief complaint of chest pain or cardiac symptoms (epigastric, neck, jaw, or arm pain, discomfort or pressure without an apparent noncardiac source).
- Greater than 18 year old chest pain/cardiac symptom patient with atleast one troponin ordered.
Exclusion Criteria:
- younger than 18 years
- older than 90 years of age
- acute ST-segment elevation on the initial ECG in at least 2 contiguous leads.
- Hemodynamic instability (pulse rate persistently greater than 100 or less than 50 beats/min or systolic blood pressure persistently below 90 mm Hg)
- clear traumatic or radiologically evident of non-cardiac etiology
- terminal non-cardiac illness
- pregnancy
- anticipated difficulty in communication or follow up
- previous enrollment
- incapability or unwillingness for consent.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Chest pain
Patients >18 years of age presenting to ED with chief complaint of chest pain or cardiac symptoms suggestive of acute coronary syndrome with at least one troponin ordered, without evidence of ST-segment elevation myocardial infarction on ECG
|
Collection of data elements for the HEART Pathway and EDACS-ADP assessments and calculation of scores to risk stratify patients into low risk or high risk
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major adverse cardiac events
Time Frame: 30 days from initial patient encounter
|
30 day major adverse cardiac event defined as death, cardiac arrest, emergency revascularization procedure (coronary artery bypass grafting, stent placement, or other percutaneous coronary intervention), cardiogenic shock, ventricular arrhythmia needing intervention, high-degree atrioventricular block needing intervention, and acute myocardial infarction.
|
30 days from initial patient encounter
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Farya Rehman, MBBS, Zayed Military Hospital
- Study Chair: Rauda Al Nuami, MBBS, Zayed Military Hospital
Publications and helpful links
General Publications
- Than MP, Pickering JW, Aldous SJ, Cullen L, Frampton CM, Peacock WF, Jaffe AS, Goodacre SW, Richards AM, Ardagh MW, Deely JM, Florkowski CM, George P, Hamilton GJ, Jardine DL, Troughton RW, van Wyk P, Young JM, Bannister L, Lord SJ. Effectiveness of EDACS Versus ADAPT Accelerated Diagnostic Pathways for Chest Pain: A Pragmatic Randomized Controlled Trial Embedded Within Practice. Ann Emerg Med. 2016 Jul;68(1):93-102.e1. doi: 10.1016/j.annemergmed.2016.01.001.
- Al-Shamsi S, Regmi D, Govender RD. Incidence of cardiovascular disease and its associated risk factors in at-risk men and women in the United Arab Emirates: a 9-year retrospective cohort study. BMC Cardiovasc Disord. 2019 Jun 17;19(1):148. doi: 10.1186/s12872-019-1131-2.
- Eslick GD, Jones MP, Talley NJ. Non-cardiac chest pain: prevalence, risk factors, impact and consulting--a population-based study. Aliment Pharmacol Ther. 2003 May 1;17(9):1115-24. doi: 10.1046/j.1365-2036.2003.01557.x.
- Litt HI, Gatsonis C, Snyder B, Singh H, Miller CD, Entrikin DW, Leaming JM, Gavin LJ, Pacella CB, Hollander JE. CT angiography for safe discharge of patients with possible acute coronary syndromes. N Engl J Med. 2012 Apr 12;366(15):1393-403. doi: 10.1056/NEJMoa1201163. Epub 2012 Mar 26.
- Than M, Flaws D, Sanders S, Doust J, Glasziou P, Kline J, Aldous S, Troughton R, Reid C, Parsonage WA, Frampton C, Greenslade JH, Deely JM, Hess E, Sadiq AB, Singleton R, Shopland R, Vercoe L, Woolhouse-Williams M, Ardagh M, Bossuyt P, Bannister L, Cullen L. Development and validation of the Emergency Department Assessment of Chest pain Score and 2 h accelerated diagnostic protocol. Emerg Med Australas. 2014 Feb;26(1):34-44. doi: 10.1111/1742-6723.12164. Epub 2014 Jan 15.
- Chapman AR, Lee KK, McAllister DA, Cullen L, Greenslade JH, Parsonage W, Worster A, Kavsak PA, Blankenberg S, Neumann J, Sorensen NA, Westermann D, Buijs MM, Verdel GJE, Pickering JW, Than MP, Twerenbold R, Badertscher P, Sabti Z, Mueller C, Anand A, Adamson P, Strachan FE, Ferry A, Sandeman D, Gray A, Body R, Keevil B, Carlton E, Greaves K, Korley FK, Metkus TS, Sandoval Y, Apple FS, Newby DE, Shah ASV, Mills NL. Association of High-Sensitivity Cardiac Troponin I Concentration With Cardiac Outcomes in Patients With Suspected Acute Coronary Syndrome. JAMA. 2017 Nov 21;318(19):1913-1924. doi: 10.1001/jama.2017.17488. Erratum In: JAMA. 2018 Mar 20;319(11):1168. Soerensen NA [corrected to Sorensen NA].
- Chapman AR, Anand A, Boeddinghaus J, Ferry AV, Sandeman D, Adamson PD, Andrews J, Tan S, Cheng SF, D'Souza M, Orme K, Strachan FE, Nestelberger T, Twerenbold R, Badertscher P, Reichlin T, Gray A, Shah ASV, Mueller C, Newby DE, Mills NL. Comparison of the Efficacy and Safety of Early Rule-Out Pathways for Acute Myocardial Infarction. Circulation. 2017 Apr 25;135(17):1586-1596. doi: 10.1161/CIRCULATIONAHA.116.025021. Epub 2016 Dec 29.
- Shin YS, Ahn S, Kim YJ, Ryoo SM, Sohn CH, Kim WY. External validation of the emergency department assessment of chest pain score accelerated diagnostic pathway (EDACS-ADP). Am J Emerg Med. 2020 Nov;38(11):2264-2270. doi: 10.1016/j.ajem.2019.09.019. Epub 2019 Nov 15.
- Hess EP, Brison RJ, Perry JJ, Calder LA, Thiruganasambandamoorthy V, Agarwal D, Sadosty AT, Silvilotti ML, Jaffe AS, Montori VM, Wells GA, Stiell IG. Development of a clinical prediction rule for 30-day cardiac events in emergency department patients with chest pain and possible acute coronary syndrome. Ann Emerg Med. 2012 Feb;59(2):115-25.e1. doi: 10.1016/j.annemergmed.2011.07.026. Epub 2011 Sep 1.
- Stopyra J, Snavely AC, Hiestand B, Wells BJ, Lenoir KM, Herrington D, Hendley N, Ashburn NP, Miller CD, Mahler SA. Comparison of accelerated diagnostic pathways for acute chest pain risk stratification. Heart. 2020 Jul;106(13):977-984. doi: 10.1136/heartjnl-2019-316426. Epub 2020 Apr 8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EDACS vs HEART pathway in UAE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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