Comparison of Accelerated Diagnostic Pathways for Acute Chest Pain in Emergency Departments in the United Arab Emirates

NCT05532787 | Unknown

• 1 other identifier: EDACS vs HEART pathway in UAE
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 5

Brief Summary

This is a prospective four-site cohort study, which will accrue adults with symptoms concerning for acute coronary syndrome over a period of 12 months. After application of inclusion and exclusion criteria, Physicians will complete HEART Pathway and EDACS risk assessments on eligible participants. Major adverse cardiac events as defined by our study will be assessed at 30 days using electronic health record, telephone contact, and national death and health events search. Outcomes for all patients will then be matched against the existing pathway of care for acute chest pain that is being used currently to compare diagnostic accuracy of both scores to diagnose low risk chest pain in this population. The objective of this study is to compare the test performance of the HEART and EDACS pathway in a large cohort of patients presenting to the Emergency department with chest pain in the United Arab Emirates and to determine if either accelerated diagnostic pathway can achieve a negative predictive value of ≥99% for 30-day MACE as well as to externally validate EDACS-ADP and the HEART pathway in the UAE population and gain further insight into the applicability of these decision-making aids in different clinical settings in order to assess which score is best suitable for the UAE population. Our third objective is to compare the effectiveness of both scores to the existing framework for chest pain work up in each hospital and have the opportunity to unify Emergency Departments in their chest pain pathways in the UAE. The investigators will be testing the null hypothesis that there is no difference in using the EDACS-ADP to safely classify patients to low-risk category and early discharge from the ED versus the HEART pathway.

Conditions

Acute Coronary Syndrome; Chest Pain

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac events

  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

Study Arms (1)

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

Other: Application of acute chest pain risk stratification scores (HEART and EDACS)

Interventions

Application of acute chest pain risk stratification scores (HEART and EDACS) OTHER

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

Chest pain

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients presenting with symptoms of chest pain or cardiac symptoms to the Emergency Department at Zayed Military Hospital, Tawam Hospital, Shaikh Shakhbout Medical City and Cleveland Clinic Abu Dhabi in the United Arab Emirates

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zayed Military Hospital: lead

Study Sites (5)

Cleveland Clinic Abu Dhabi

Abu Dhabi, 00000, United Arab Emirates

NOT YET RECRUITING

Sheikh Khalifa Medical City

Abu Dhabi, 00000, United Arab Emirates

RECRUITING

Sheikh Shakhbout Medical City

Abu Dhabi, 00000, United Arab Emirates

RECRUITING

Zayed Military Hospital

Abu Dhabi, 00000, United Arab Emirates

RECRUITING

Tawam Hospital

Al Ain City, 00000, United Arab Emirates

RECRUITING

Related Publications (10)

• 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.

  PMID: 31208354 BACKGROUND

• 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.

  PMID: 12752348 BACKGROUND

• 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.

  PMID: 22449295 BACKGROUND

• 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.

  PMID: 24428678 BACKGROUND

• 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.

  PMID: 29127948 BACKGROUND

• 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.

  PMID: 28034899 BACKGROUND

• 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.

  PMID: 31757670 BACKGROUND

• 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.

  PMID: 21885156 BACKGROUND

• 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.

  PMID: 26947800 BACKGROUND

• 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.

  PMID: 32269131 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome; Chest Pain

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Farya Rehman, MBBS

  Zayed Military Hospital

  PRINCIPAL INVESTIGATOR

• Rauda Al Nuami, MBBS

  Zayed Military Hospital

  STUDY CHAIR

Central Study Contacts

Farya Rehman, MBBS

CONTACT

+971547497722; faryarehman@gmail.com

Rauda Al Nuami, MBBS

CONTACT

+971505639877; dr.rauda@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency Medicine Post graduate year 4 Resident Doctor

Study Record Dates

• First Submitted: September 3, 2022
• First Posted: September 8, 2022
• Study Start: February 3, 2022
• Primary Completion: February 3, 2023
• Study Completion: March 3, 2023
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

AE (5)