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Acute Coronary SyndromeNCT05532787

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

An observational study of Acute Coronary Syndrome and Chest Pain, run by Zayed Military Hospital at 5 sites in United Arab Emirates.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Acute Coronary Syndrome, Chest Pain
What is being tested?
Application of acute chest pain risk stratification scores (HEART and EDACS)
How many people
1,200 participants
Where
5 sitesUnited Arab Emirates
Study dates
3 Feb 2022to 3 Mar 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • pregnancy
  • anticipated difficulty in communication or follow up
  • previous enrollment
  • incapability or unwillingness for consent.

Trial locations and contacts

5 sites in 1 country.

Farya Rehman, MBBS contact

+971547497722

faryarehman@gmail.com

Rauda Al Nuami, MBBS contact

+971505639877

dr.rauda@hotmail.com

5 sites in 1 country

United Arab Emirates5 sites, 5 recruiting
  • Cleveland Clinic Abu Dhabi

    Abu Dhabi, 00000

    Shaza Karrar, MBBS, +971509808108, shaza.karrar114@gmail.com

    Shaza Karrar, MBBS

    Not yet recruiting
  • Sheikh Khalifa Medical City

    Abu Dhabi, 00000

    Maryam Siddiqi, MBBS, +971501191178, masiddiqi@seha.ae

    Maryam Siddiqi, MBBS

    Recruiting
  • Sheikh Shakhbout Medical City

    Abu Dhabi, 00000

    Aya Doudin, MBBS, +971503951593, ayadodin@yahoo.com

    Aya Doudin, MBBS

    Recruiting
  • Zayed Military Hospital

    Abu Dhabi, 00000

    Rauda Al Nuami, MBBS, +971505639877, dr.rauda@gmail.com

    Ruqaya Al Afeefi, MBBS, +971544484724, ruq.alafeefi@gmail.com

    Recruiting
  • Tawam Hospital

    Al Ain City, 00000

    Amani Al Abdouli, MBBS, +971592662287, alabdouli.aman12@gmail.com

    Amani Al Abdouli, MBBS

    Recruiting

Other trials in United Arab Emirates

About this study

Official title: 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

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.

Read the 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.

Being tested
Application of acute chest pain risk stratification scores (HEART and EDACS)
Medical subject headings
Acute Coronary Syndrome, Chest Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT05532787
Study groupRoleWhat they receive
Chest painPatients >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
Receives: Other: Application of acute chest pain risk stratification scores (HEART and EDACS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 30 days from initial patient encounter

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2022
  2. Study start3 Feb 2022
  3. Primary completion3 Feb 2023 (estimated)
  4. Study completion3 Mar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05532787
Sponsor's protocol ID
EDACS vs HEART pathway in UAE
Status last verified
Sep 2022
First submitted
3 Sep 2022
Last updated
14 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared with other researchers. Data will only be accessed and seen by the co-investigators listed in this research.

Publications

  • 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.

    PubMed 31208354
  • 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.

    PubMed 12752348
  • 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.

    PubMed 22449295
  • 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.

    PubMed 24428678
  • 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.

    PubMed 29127948
  • 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.

    PubMed 28034899
  • 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.

    PubMed 31757670
  • 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.

    PubMed 21885156
  • 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.

    PubMed 26947800
  • 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.

    PubMed 32269131

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Coronary Syndrome and Chest Pain, run by Zayed Military Hospital at 5 sites in United Arab Emirates.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Farya Rehman, MBBS (+971547497722, faryarehman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major adverse cardiac events (time frame: 30 days from initial patient encounter). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05532787, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.

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