Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05857735
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2023-05-02
Brief Title:
Kuwait Heart Foundation Registry of Acute Coronary Events
Sponsor:
Gulf Heart Association
Organization:
Gulf Heart Association
Study Overview
Official Title:
Kuwait Heart Foundation Registry of Acute Coronary Events
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KHF RACE
Brief 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 Users 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 10000 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 hisher 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 eg 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
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 hisher 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None