Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05857735 |
Other study ID # |
KHF1 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
May 15, 2023 |
Est. completion date |
October 2025 |
Study information
Verified date |
March 2024 |
Source |
Gulf Heart Association |
Contact |
Mohammad Zubaid, Professor |
Phone |
+965-99644173 |
Email |
mohammed.zubaid[@]ku.edu.kw |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical 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 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.
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:
1. Enrol all consecutive patients who get admitted to hospital.
2. Patients or their relatives should consent for enrolment in the registry.
3. 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:
1. Determine the incidence of ACS in Kuwait.
2. 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.
3. Study the influence of modifiable and non-modifiable risk factors on outcomes, e.g.,
influence of age, diabetes, hypertension.
4. Evaluate current ACS practices in Kuwait by examining degree of physician adherence to
guidelines of ACS management.
5. Examine the applicability of Global Registry of Acute Coronary Events (GRACE) risk score
to our patient populations.
6. Create "Kuwait acute coronary syndrome risk score" (Kuwait risk score), a risk score
that better assesses outcomes in our patient population.
7. Compare the effect of current management of ACS in Kuwait, with our previously published
data in 2007 on patients' outcomes.
8. Compare our management and outcomes (primary and secondary endpoints) to published
international outcomes.
9. 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.