- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00383955
Comparison of Screening Tools for Coronary Artery Disease
Comparison of Screening Tools for Coronary Artery Disease With Thallium Scintigraphy in Adult Population in Karachi.
Study Overview
Status
Conditions
Detailed Description
Design: The proposed study is a cross sectional study of a population sample of 450 subjects aged > 40 years, and stratified by gender, residing in 12 randomly selected communities in Karachi, Pakistan.
The target population for this study would be drawn from an existing population based study entitled "Population based strategies for effective control of high blood pressure in Pakistan" (parent study), conducted by the primary supervisor and study director (TJ) in Karachi Subjects aged > 40 years would be eligible. Detailed information on each participant would be obtained from data collected for the parent study. This includes a) socio-demographic characteristics such as level of education, occupation, economic status, ethnicity, tobacco use , physical activity defined on the basis of International Physical Activity Questionnaire, dietary habits (food frequency questionnaire), family history of CAD, and the WHO standard Rose questionnaire (RQ) for coronary artery disease (CAD) (b) anthropometry including height, weight, waist and hip circumference (c) laboratory tests including fasting blood glucose, lipid profile, serum creatinine, and urine albumin to creatinine ratio. The community health workers (CHW) would administer RQ and obtain 12-lead EKG. They would give an appointment to subjects for MPI at the Aga Khan University Hospital. Each individual will then go through an exercise treadmill test (symptom limited Bruce or modified Bruce protocols) if able to walk, or pharmacological stress by the infusion of dobutamine or dipyridamole if unable to walk. The results of MPI study would be delivered to the subjects with interpretation by cardiologists, and referral to a physician (as appropriate).
Classification of Screening instruments: ECG will be Minnesota coded by two trained and independent coders, and discrepant reports will be resolved with a third independent coder. All cases of probable or possible CAD on Minnesota coding of ECG would be classified as "MC ECG positive for CAD" RQ will be coded according to standardized criteria into "positives for "angina" and "history of possible infarction" . Presence of either one would be classified as "RQ positive for CAD".
Study Type
Enrollment
Contacts and Locations
Study Contact
- Name: Dr.Shazia S Abbas
- Phone Number: 92 21 4864860
- Email: shazia.shehzad@aku.edu
Study Contact Backup
- Name: Dr. Tazeen H Jafar, MD, MPH
- Phone Number: 4818 92 21 4930051
- Email: tazeen.jafar@aku.edu
Study Locations
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Sindh
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Karachi, Sindh, Pakistan
- Recruiting
- Aga Khan University, Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult resident of Karachi residing in selected clusters
- Age > 40 years
Exclusion Criteria:
- Clinical Heart Failure
- Severe Disease e.g. Cancer
- Pregnant or lactating women
- People with limited mobility
- People not willing to participate
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Dr. Tazeen H Jafar, MD, MPH, Aga Khan University
- Principal Investigator: Dr. Shazia S Abbas, Aga Khan University
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 078440/Z/05/Z
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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