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National Cardiovascular Disease Database - Acute Coronary Syndrome Registry

National Cardiovascular Disease Database - Acute Coronary Syndrome Registry

NCVD_ACS

General Information
NMRR ID
NMRR-07-38-164
Date of NMRR Registration
23/09/2005 04:18:00
Type of Submission
Investigator Initiated Research (IIR)
Protocol ID
CEU05-07
Research Scope
Clinical
Research Type
Registry / Biobanking / Clinical Database
Study Information
RMK Priority Area
Research Area

Disease Area


Investigational Product/ Process /Intervention
Research Level
Research Description/ Research Lay Summary
Continuous and systematic data collection on all aspects of Acute Coronary Syndromes relevant to its prevention, management and treatment evaluation in Malaysia.
Research Keyword
Acute Coronary Syndromes
Cardiovascular Disease
Research Objective
1. Determine the number and the time trend of acute coronary syndromes in Malaysia.
2. Determine the socio demographic profiles of these patients to better identify the
high risk group in our Malaysian population
3. Evaluate and monitor the outcomes based on selected performance indicators
4.Stimulate and facilitate research using this database
Inclusion & Exclusion Criteria
Inclusion Criteria
- Age 18 and above years old
- Seen in any of the participating sites.
- Acute coronary syndromes is defined as the presence of at least 2 of the following:
o Clinical Presentation:
Typical anginal pain at rest lasting more than 20 minutes, or
New-onset angina of at least CCS grade III severity, or
Previously diagnosed angina that has become more frequent, longer in duration or more easily provoked, or
Acute decompensated heart failure in a patient with known ischemic heart disease.
o Electrocardiography
ST segment depression by more than 0.05mV in 2 or more contiguous leads.
Marked symmetrical T-wave inversion by more than 0.2mV in the precordial leads.
New bundle branch block
Sustained ventricular tachycardia
o Cardiac enzymes:
Typical pattern of elevation of conventional cardiac enzymes including creatine kinase (CK), aspartate transaminase (AST) and lactate dehydrogenase (LDH).
Elevated Troponin T or I
Elevated isoenzyme CK-MB
Exclusion Criteria
- Age 18 and above years old
- Seen in any of the participating sites.
- Acute coronary syndromes is defined as the presence of at least 2 of the following:
o Clinical Presentation:
Typical anginal pain at rest lasting more than 20 minutes, or
New-onset angina of at least CCS grade III severity, or
Previously diagnosed angina that has become more frequent, longer in duration or more easily provoked, or
Acute decompensated heart failure in a patient with known ischemic heart disease.
o Electrocardiography
ST segment depression by more than 0.05mV in 2 or more contiguous leads.
Marked symmetrical T-wave inversion by more than 0.2mV in the precordial leads.
New bundle branch block
Sustained ventricular tachycardia
o Cardiac enzymes:
Typical pattern of elevation of conventional cardiac enzymes including creatine kinase (CK), aspartate transaminase (AST) and lactate dehydrogenase (LDH).
Elevated Troponin T or I
Elevated isoenzyme CK-MB
Study Timeline
Expected / Actual Date Study Starts - First Enrolment of subject / Collecting data
Sep, 11 2005
Expected / Actual Date Study Completed
Sep, 11 2025
Expected / Actual Duration of Study Enrollment / Data Collection
1043 weeks
Subject (Sample Size) Description
Age Range :
Gender :
Outcome Measure
-


Biospecimen Collection & Archiving
-


Current Study Status
Recruiting
Sites
Sites Description
No. of site :
Sites List
National Heart Institute
Pulau Pinang Hospital
Sultanah Aminah Hospital (HSA) Johor Bharu
Sarawak General Hospital
Clinical Research Centre (CRC), Kuala Lumpur Hospital
HOSPITAL SUNGAI BULOH
HOSPITAL PUTRAJAYA
Hospital Kajang
HOSPITAL KUALA LUMPUR
HOSPITAL SERDANG
HOSPITAL AMPANG
Team Members
Principal Investigator Information
Dr. Lee Chuey Yan
Sultanah Aminah General Hospital, Johor Bahru
Sponsor
MOH/Research & Technical Support
Ethical Application Status
Study URL
-
-
Individual Clinical Trial Participant–level Data of Individual Participant Data (IPD) Sharing
Result Summary