Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00383955
Status:
UNKNOWN
Last Update Posted:
2006-10-04
First Post:
2006-10-03
Brief Title:
Comparison of Screening Tools for Coronary Artery Disease
Sponsor:
Aga Khan University
Organization:
Aga Khan University
Study Overview
Official Title:
Comparison of Screening Tools for Coronary Artery Disease With Thallium Scintigraphy in Adult Population in Karachi
Status:
UNKNOWN
Status Verified Date:
2006-10
Last Known Status:
RECRUITING
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:
None
Brief Summary:
Coronary artery disease CAD is a silent killer that may go undetected for years It is the leading cause of death with no limitation to geographic boundaries accounting to about 167 million deaths world wide Different studies have shown that South Asians populations are more prone to CAD where it is emerging as an epidemic According to a study conducted in Karachi it is estimated that the overall prevalence of cardiovascular diseases in Pakistan is 269 with 237 in men and 300 in women However tools for measuring CAD have not being adequately validated This study is designed to develop screening tools and to determine test characteristics of Rose Questionnaire and Minnesota Coded ECG alone and in combination for diagnosis of CAD using MPI as gold standard in Pakistan
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None