Clinical trial NCT05532787: Comparison of Accelerated Diagnostic Pathways for Acute Chest Pain in Emergency Departments in the United Arab Emirates
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Chest Pain
Lead sponsor: Zayed Military Hospital
Sponsor class: OTHER_GOV
First posted: 2022-09-08
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Major adverse cardiac events
timeFrame: 30 days from initial patient encounter
Secondary outcomes:
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: Cleveland Clinic Abu Dhabi
city: Abu Dhabi
country: United Arab Emirates
facility: Sheikh Khalifa Medical City
city: Abu Dhabi
country: United Arab Emirates
facility: Sheikh Shakhbout Medical City
city: Abu Dhabi
country: United Arab Emirates
facility: Zayed Military Hospital
city: Al Ain
country: United Arab Emirates
facility: Tawam Hospital
Study officials:
affiliation: Zayed Military Hospital
name: Farya Rehman, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Zayed Military Hospital
name: Rauda Al Nuami, MBBS
role: STUDY_CHAIR
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