Cardiovascular DiseaseNCT00383955
Comparison of Screening Tools for Coronary Artery Disease
An observational study of Cardiovascular Disease, run by Aga Khan University at 1 site in Pakistan.
Trial 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 16.7 million deaths world wide. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cardiovascular Disease
- How many people
- 450 participants
- Where
- 1 sitePakistan
- Study dates
- Oct 2006to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult resident of Karachi residing in selected clusters
- Age > 40 years
Who cannot join
- Clinical Heart Failure
- Severe Disease e.g. Cancer
- Pregnant or lactating women
- People with limited mobility
- People not willing to participate
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University, Hospital
Karachi, Sindh
About this study
Official title: Comparison of Screening Tools for Coronary Artery Disease With Thallium Scintigraphy in Adult Population in Karachi.
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 16.7 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 26.9% with 23.7% in men and 30.0% 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.
Read the 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".
- Conditions
- Cardiovascular Disease
- Medical subject headings
- Cardiovascular Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2006 (estimated)
- Study startOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Other
- Enrolment
- 450 participants
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust
- Investigators
- Dr. Tazeen H Jafar, MD, MPH, Study director, Aga Khan UniversityDr. Shazia S Abbas, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00383955
- Sponsor's protocol ID
- 078440/Z/05/Z
- Status last verified
- Oct 2006
- First submitted
- 3 Oct 2006
- Last updated
- 4 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Screening Tools for Coronary Artery Disease With Thallium Scintigraphy in Adult Population in Karachi.
- ClinicalTrials.gov ID
- NCT00383955
- Acronym / sponsor ID
- 078440/Z/05/Z
- Conditions
- Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Wellcome Trust
- Study start
- Oct 2006
- First posted
- 4 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 16.7 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 26.9% with 23.7% in men and 30.0% 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".
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult resident of Karachi residing in selected clusters
- Age > 40 years
Key exclusion criteria (5 listed)
- Clinical Heart Failure
- Severe Disease e.g. Cancer
- Pregnant or lactating women
- People with limited mobility
- People not willing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Tazeen H Jafar, MD, MPH study director
Aga Khan University
Dr. Shazia S Abbas principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr.Shazia S Abbas (92 21 4864860, shazia.shehzad@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2006.