Testing a personalized heart treatment for diverse patients in the UAE: The EmHeart Study
| ISRCTN | ISRCTN88901451 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88901451 |
- Submission date
- 08/10/2024
- Registration date
- 16/10/2024
- Last edited
- 28/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
This study looks at how a specific gene, CYP2C19, affects the way a heart medication called clopidogrel works. Some people have variations in this gene that make the medication less effective, which can increase their risk of heart problems. The study aims to see if using genetic information to guide treatment can reduce these risks for patients in the UAE.
Who can participate?
Any patient aged 18 or older who has symptoms of acute coronary syndrome (a type of heart problem) confirmed by a doctor, is scheduled to receive antiplatelet therapy, and has signed a consent form can participate.
What does the study involve?
Participants will be randomly assigned to receive either the standard treatment or a treatment plan guided by their genetic information. They will be monitored to see if the genetic-guided treatment reduces the risk of heart problems and other adverse events.
What are the possible benefits and risks of participating?
The potential benefit is a more effective treatment plan that could reduce the risk of heart problems. However, there may be risks, such as side effects from the medication or the possibility that the genetic-guided treatment may not be more effective than the standard treatment.
Where is the study run from?
The study is being conducted at the United Arab Emirates University in Al-Ain, Abu Dhabi, UAE.
When is the study starting and how long is it expected to run for?
January 2016 June 2024
Who is funding the study?
The study is funded by the Ministry of Education (MOE) of the United Arab Emirates.
Who is the main contact?
Professor Bassam R. Ali, Bassam.ali@uaeu.ac.ae
Contact information
Public, Principal Investigator
Al-Ain, Abu-Dhabi, UAE
Al-Ain, Abi Dhabi
15551
United Arab Emirates
 ORCID ID |
0000-0003-1306-6618 |
|---|---|
| Phone | +971 37137470 |
| bassam.ali@uaeu.ac.ae |
Scientific
Abu-Dhabi. UAE
Abu-Dhabi
-
United Arab Emirates
| ORCID ID |
0000-0001-6090-5969 |
|---|---|
| Phone | +971 544423516 |
| 202090172@uaeu.ac.ae |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Safety, Efficacy |
| Participant information sheet | No participant information sheet available |
| Scientific title | Evaluating the efficacy and safety of the CYP2C19-pharmacogenomic-guided clopidogrel treatment approach for acute coronary syndrome patients in the United Arab Emirates multi-ethnic population: “The EmHeart Study” |
| Study acronym | Clopedogril-EmHeart study |
| Study objectives | CYP2C19 genotype-guided use of oral antiplatelets compared to non-genotype-guided standard of care therapy would significantly reduce the risk of ischemic events and adverse events in CYP2C19 LOF variants carriers after the occurrence of ACS among a sample from the UAE population |
| Ethics approval(s) |
1. Approved 29/06/2020, Abu Dhabi health Reserarch and technology ethics committee (Abu-Dhabi-UAE, Abu-Dhabi, 5674, United Arab Emirates; +971 24449822; admt@doh.gov.ae), ref: DOH/CVDC/2020/1187 2. Approved 21/09/2022, Abu Dhabi health Reserarch and technology ethics committee (AbuDhabi-UAE, AbuDhabi, 5674, United Arab Emirates; +971 24449822; admt@doh.gov.ae), ref: DOH/CVDC/2022/1458 3. Approved 09/11/2023, Abu Dhabi health Reserarch and technology ethics committee (Abu-Dhabi, Abu-Dhabi, 5674, United Arab Emirates; +971 24449822; admt@doh.gov.ae), ref: DOH/CVDC/2023/1952 4. Approved 09/03/2022, MCME research and ethics committee (Mediclinic Coporate office-Dubai, UAE, Dubai, 123812, United Arab Emirates; +971 45122730; MCME-ResearchOffice@mediclinic.ae), ref: MCME.CR.213.MAIN.2021 5. Approved 05/04/2023, The United Arab Emirates University Human Medical Research Ethics Committee (Al-Ain, Abu-Dhabi, UAE, Al-Ain, Abu-Dhabi, 15551, United Arab Emirates; + 971 3 713 5900; research.office@uaeu.ac.ae), ref: SNA/FA/2020-14 6. Approved 27/10/2021, Abu Dhabi health Reserarch and technology ethics committee (Abu-Dhabi-UAE, Abu-Dhabi, 5674, United Arab Emirates; +971 24449822; admt@doh.gov.ae), ref: DOH/CVDC/2021/1519 |
| Health condition(s) or problem(s) studied | Acute coronary syndrome (ACS) |
| Intervention | Randomized controlled trial, Patients taking anti-platelets were randomly allocated into intro either interventional or control arm. Patients were randomized based on automated software called castorEDC. Patients in the interventional arm were genotyped for CYP2C19 variants. If the patient was identified as CYP2C19 intermediate metabolizer (IM) or poor metabolizer (PM), the genetic report recommended switching clopidogrel to ticagrelor for at least three months. If the patient was a normal metabolizer (NM), rapid Metabolizer (RM), or ultra-rapid Metabolizer (URM), no changes were recommended. At the same time, patients from the control arm followed the standard of care for ACS management based on the physician's decision, without genetic testing (genetic testing done at the end of the study) |
| Intervention type | Genetic |
| Primary outcome measure | Composite of major adverse cardiovascular events (MACE), including myocardial infarction (MI), ischemic stroke, definite stent thrombosis, severe recurrent ischemia (angina requiring PCI), or death within 12 months following the ACS event measured using patient records at baseline, 4 weeks, 12 weeks, and 12 months |
| Secondary outcome measures | Major or minor bleeding events, assessed according to the thrombolysis in myocardial infarction (TIMI) criteria measured using patient records and patient interviews at baseline, 4 weeks, 12 weeks, and 12 months |
| Overall study start date | 01/01/2016 |
| Completion date | 22/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 207 |
| Total final enrolment | 169 |
| Key inclusion criteria | 1. Arabian Gulf patients 2. Above 18 years old 3. Diagnosed with acute coronary syndrome (ACS) 4. Planned to take anti-platelets for at least one year |
| Key exclusion criteria | 1. Patients with severe illness 2. Severe renal or hepatic impairment 3. Patients not expected to take dual anti-platelets for a minimum of one year 4. Patients taking long-term anti-coagulants 5. Patients with active tumors and currently under chemotherapy 6. Patients with active bleeding or history of significant bleeding in the past three months 7. Hematologic problems: 7.1. WBC <2 x 10^9 /l 7.2. Platelet counts <100 x 10^9 /l 7.3. Hematocrit <30% |
| Date of first enrolment | 28/10/2021 |
| Date of final enrolment | 28/03/2023 |
Locations
Countries of recruitment
- United Arab Emirates
Study participating centres
Al-Ain
15258
United Arab Emirates
Al-ain
14444
United Arab Emirates
Al-Ain
-
United Arab Emirates
AbuDhabi
130972
United Arab Emirates
Sponsor information
University/education
Al-Ain, Abu-Dhabi
Al-Ain
15551
United Arab Emirates
| Phone | +971 800-8238 |
|---|---|
| research.office@uaeu.ac.ae | |
| Website | https://www.uaeu.ac.ae/en/ |
"ROR" |
https://ror.org/01km6p862 |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 10/10/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer reviewed journal |
| IPD sharing plan | The de-identified individual participant data (IPD) collected from the study will be available upon reasonable request. Requests for data access should be directed to the corresponding author, and access will be granted upon approval from the study's funding body and the institutional review board (IRB) committee. laboon_2009@hotmail.com |
Editorial Notes
28/02/2025: Contact details updated.
03/12/2024: Internal review.
08/10/2024: Trial's existence confirmed by United Arab Emirates University.
