ACSKHF RACENCT05857735
Kuwait Heart Foundation Registry of Acute Coronary Events
An observational study of ACS, run by Gulf Heart Association at 1 site in Kuwait.
Trial summary
Acute coronary syndrome (ACS) is the most common presentation of Coronary Artery Disease (CAD). It causes significant morbidity and mortality. The Gulf Registry of Acute Coronary Events (Gulf RACE) was conducted in 2007 and filled a wide gap in our understanding of ACS and its management in Kuwait and the Arabian Gulf… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ACS
- How many people
- 10,812 participants
- Where
- 1 siteKuwait
- Study dates
- 15 May 2023to 30 Jun 2025
- How long will I take part?
- 6 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are admitted to any of the eight general hospitals in Kuwait with a diagnosis of ACS. The sample size will be 10,000 patients. ACS diagnosis includes ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI) and unstable angina.
Who may be able to join
- Patient is admitted to hospital with admission diagnosis of ACS.
- Patient or a relative consent to enrolment in the registry.
Who cannot join
- 1- Refusal or inability to consent for enrolment
Trial locations and contacts
1 site in 1 country.
About this study
Acute coronary syndrome (ACS) is the most common presentation of Coronary Artery Disease (CAD). It causes significant morbidity and mortality. The Gulf Registry of Acute Coronary Events (Gulf RACE) was conducted in 2007 and filled a wide gap in our understanding of ACS and its management in Kuwait and the Arabian Gulf region. However, the management of ACS has undergone tremendous advances over the last two decades involving pharmacotherapy and device therapy. Practice guidelines have also changed over the last decade. For example, in 2007, there was no catheterization laboratory in any of the general hospitals in Kuwait, primary percutaneous coronary intervention (PCI) was not being practiced, and the rate of in-hospital cardiac catheterization for all ACS patients was very low at around 10%. Currently, of the eight general hospitals in Kuwait, six have catheterization laboratories and five of the six serve as primary PCI centers. There is no contemporary ACS registry in Kuwait, studying its incidence, management, and influence of current changes in clinical practice on patients' outcomes. This multicentre disease-based, country-wide registry is guided by the American Heart Association policy statement for expanding the applications of existing and future clinical registries and the User's Guide published by the Agency for Health care Research and Quality guidance.
Read the detailed description
This is a prospective, multicentre, country-wide registry of patients who are admitted to any of the eight general hospitals in Kuwait with a diagnosis of ACS over 6-months or more to include 10,000 patients. ACS diagnosis includes ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI) and unstable angina.
The protocol mandates the following basic points:
- Enrol all consecutive patients who get admitted to hospital.
- Patients or their relatives should consent for enrolment in the registry.
- Follow-up of all patients for 30 days from the admission event.
The Principal Investigator has formed a steering committee and drafted a protocol and case report form (CRF). The steering committee members will meet to finalize the protocol and the CRF. Then an investigators meeting will be held to go over the fine details of the protocol and CRF and to instruct the investigators on how to use the online CRFs.
Data entry will be entered online. Quality Control Surveyors will carry out quality control visits. This will involve the inspection of 5% of the data source (hospital files) of enrolled patients against entered patient data for their accuracy. Centres that are identified to be consistently inaccurate will be warned and might be withdrawn from the registry if necessary. This quality control process will be carried out at 1 month and again at 3 months, from the start of the study. It will later be decided whether other subsequent checks would be required. In addition, the Chief Site Officer (CSO) in each hospital will be required to carry out quality control checks at his/her own hospital. This will involve the random checking of 2 files per week involving checking the online CRF and data source.
The different elements of the form will be filled out prospectively during patient stay in the hospital and subsequently at follow-up. All patients will be followed up for 30 days post ACS.
The registry and data collection will be conducted prospectively with the following objectives:
- Determine the incidence of ACS in Kuwait.
- Examine the risk factors and outcomes of patients with ACS in Kuwait. Outcomes include mortality, myocardial infarction (MI), cerebrovascular accident (CVA), bleeding, cardiogenic shock, heart failure and others.
- Study the influence of modifiable and non-modifiable risk factors on outcomes, e.g., influence of age, diabetes, hypertension.
- Evaluate current ACS practices in Kuwait by examining degree of physician adherence to guidelines of ACS management.
- Examine the applicability of Global Registry of Acute Coronary Events (GRACE) risk score to our patient populations.
- Create "Kuwait acute coronary syndrome risk score" (Kuwait risk score), a risk score that better assesses outcomes in our patient population.
- Compare the effect of current management of ACS in Kuwait, with our previously published data in 2007 on patients' outcomes.
- Compare our management and outcomes (primary and secondary endpoints) to published international outcomes.
- Establish a network of hospitals and investigators who are willing to do research. This network will serve as a nucleus for future country-wide projects.
- Conditions
- ACS
- Being tested
- Observational registry with no intervention.
- Keywords
- Mortality, Inhospital MACE, 30-day MACE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational registry with no intervention.Other
No intervention
| Study group | Role | What they receive |
|---|---|---|
| ACS patients | Patients admitted to hospital with diagnosis of ACS. Receives: Other: Observational registry with no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
To measure the adverse outcome of in-hospital mortality in ACS patients in Kuwait.
Measured: through study completion, an average of 6 months
Major Adverse Cardiac Events (MACE)
To measure the in-hospital adverse outcomes like myocardial infarction (MI), cerebrovascular accident (CVA), bleeding, cardiogenic shock, heart failure and others in ACS patients in Kuwait.
Measured: through study completion, an average of 6 months
Secondary outcomes (6)
Mortality
To measure the adverse outcome mortality 30 days post discharge in ACS patients in Kuwait.
Measured: 30 days from discharge
Major Adverse Cardiac Events (MACE)
To measure the adverse outcomes like myocardial infarction (MI), cerebrovascular accident (CVA), bleeding, cardiogenic shock, heart failure and others 30 days post discharge in ACS patients in Kuwait.
Measured: 30 days from discharge
Rehospitalization
To measure the rehospitalization rate within 30 days post discharge in ACS patients in Kuwait.
Measured: within 30 days from discharge
Revascularization
To measure the revascularization rate within 30 days post discharge in ACS patients in Kuwait.
Measured: within 30 days from discharge
Lipid level control
To measure the state of lipid level control at 6 months from ACS event
Measured: At 6 months from ACS event
Efficacy of lipid lowering agents
To review the types and dosages of lipid lowering agents used.
Measured: At 6 months from ACS event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start15 May 2023
- Primary completion25 Nov 2024
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 10,812 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Gulf Heart Association
- Sponsor type
- University, hospital or other
- Collaborators
- Servier, Sanofi, Beshara company, Kuwait Heart Foundation
- Responsible party
- Principal investigator, Mohammad Zubaid, Gulf Heart Association
- Investigators
- Mohammad Zubaid, Professor, Principal investigator, Kuwait University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857735
- Sponsor's protocol ID
- KHF1
- Acronym
- KHF RACE
- Status last verified
- Mar 2025
- First submitted
- 2 May 2023
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kuwait Heart Foundation Registry of Acute Coronary Events
- ClinicalTrials.gov ID
- NCT05857735
- Acronym / sponsor ID
- KHF RACE / KHF1
- Conditions
- ACS
- Keywords
- Mortality, Inhospital MACE, 30-day MACE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,812 participants (actual)
- Lead sponsor
- Gulf Heart AssociationUniversity, hospital or other
- Collaborators
- Servier, Sanofi, Beshara company, Kuwait Heart Foundation
- Study start
- 15 May 2023 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute coronary syndrome (ACS) is the most common presentation of Coronary Artery Disease (CAD). It causes significant morbidity and mortality. The Gulf Registry of Acute Coronary Events (Gulf RACE) was conducted in 2007 and filled a wide gap in our understanding of ACS and its management in Kuwait and the Arabian Gulf region. However, the management of ACS has undergone tremendous advances over the last two decades involving pharmacotherapy and device therapy. Practice guidelines have also changed over the last decade. For example, in 2007, there was no catheterization laboratory in any of the general hospitals in Kuwait, primary percutaneous coronary intervention (PCI) was not being practiced, and the rate of in-hospital cardiac catheterization for all ACS patients was very low at around 10%. Currently, of the eight general hospitals in Kuwait, six have catheterization laboratories and five of the six serve as primary PCI centers. There is no contemporary ACS registry in Kuwait, studying its incidence, management, and influence of current changes in clinical practice on patients' outcomes. This multicentre disease-based, country-wide registry is guided by the American Heart Association policy statement for expanding the applications of existing and future clinical registries and the User's Guide published by the Agency for Health care Research and Quality guidance.
Detailed description
This is a prospective, multicentre, country-wide registry of patients who are admitted to any of the eight general hospitals in Kuwait with a diagnosis of ACS over 6-months or more to include 10,000 patients. ACS diagnosis includes ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI) and unstable angina.
The protocol mandates the following basic points:
- Enrol all consecutive patients who get admitted to hospital.
- Patients or their relatives should consent for enrolment in the registry.
- Follow-up of all patients for 30 days from the admission event.
The Principal Investigator has formed a steering committee and drafted a protocol and case report form (CRF). The steering committee members will meet to finalize the protocol and the CRF. Then an investigators meeting will be held to go over the fine details of the protocol and CRF and to instruct the investigators on how to use the online CRFs.
Data entry will be entered online. Quality Control Surveyors will carry out quality control visits. This will involve the inspection of 5% of the data source (hospital files) of enrolled patients against entered patient data for their accuracy. Centres that are identified to be consistently inaccurate will be warned and might be withdrawn from the registry if necessary. This quality control process will be carried out at 1 month and again at 3 months, from the start of the study. It will later be decided whether other subsequent checks would be required. In addition, the Chief Site Officer (CSO) in each hospital will be required to carry out quality control checks at his/her own hospital. This will involve the random checking of 2 files per week involving checking the online CRF and data source.
The different elements of the form will be filled out prospectively during patient stay in the hospital and subsequently at follow-up. All patients will be followed up for 30 days post ACS.
The registry and data collection will be conducted prospectively with the following objectives:
- Determine the incidence of ACS in Kuwait.
- Examine the risk factors and outcomes of patients with ACS in Kuwait. Outcomes include mortality, myocardial infarction (MI), cerebrovascular accident (CVA), bleeding, cardiogenic shock, heart failure and others.
- Study the influence of modifiable and non-modifiable risk factors on outcomes, e.g., influence of age, diabetes, hypertension.
- Evaluate current ACS practices in Kuwait by examining degree of physician adherence to guidelines of ACS management.
- Examine the applicability of Global Registry of Acute Coronary Events (GRACE) risk score to our patient populations.
- Create "Kuwait acute coronary syndrome risk score" (Kuwait risk score), a risk score that better assesses outcomes in our patient population.
- Compare the effect of current management of ACS in Kuwait, with our previously published data in 2007 on patients' outcomes.
- Compare our management and outcomes (primary and secondary endpoints) to published international outcomes.
- Establish a network of hospitals and investigators who are willing to do research. This network will serve as a nucleus for future country-wide projects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACS patients | – | Other: Observational registry with no intervention.Patients admitted to hospital with diagnosis of ACS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are admitted to any of the eight general hospitals in Kuwait with a diagnosis of ACS. The sample size will be 10,000 patients. ACS diagnosis includes ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI) and unstable angina.
Key inclusion criteria (2 listed)
- Patient is admitted to hospital with admission diagnosis of ACS.
- Patient or a relative consent to enrolment in the registry.
Key exclusion criteria (1 listed)
- 1- Refusal or inability to consent for enrolment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational registry with no intervention.No intervention | Other | ACS patients |
Primary outcome
Mortality
Time frame: through study completion, an average of 6 months
To measure the adverse outcome of in-hospital mortality in ACS patients in Kuwait.
Major Adverse Cardiac Events (MACE)
Time frame: through study completion, an average of 6 months
To measure the in-hospital adverse outcomes like myocardial infarction (MI), cerebrovascular accident (CVA), bleeding, cardiogenic shock, heart failure and others in ACS patients in Kuwait.
6 secondary outcomes
Mortality
Time frame: 30 days from discharge
Major Adverse Cardiac Events (MACE)
Time frame: 30 days from discharge
Rehospitalization
Time frame: within 30 days from discharge
Revascularization
Time frame: within 30 days from discharge
Lipid level control
Time frame: At 6 months from ACS event
Efficacy of lipid lowering agents
Time frame: At 6 months from ACS event
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Zubaid, Professor principal investigator
Kuwait University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ACS, run by Gulf Heart Association at 1 site in Kuwait.
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 1 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: finished, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kuwait. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: through study completion, an average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2025.