- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06503341
A Hospital-Based Registry of Preventive Cardiology Clinics (PREVENT-CARD)
Assessment and Control of Modifiable Risk Factors for Primary and Secondary Prevention
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Design: observational study Duration of Study: ongoing. Sample Size: All patients presenting to preventive cardiology clinics at the National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan..
Sampling Technique: Non-probability consecutive sampling Data Collection Procedure: Verbal informed consent will be obtained from all the patients regarding their participation in the study and publication of study findings while maintaining confidentiality. Consecutive patients presenting preventive cardiology clinics at the National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan, will be included in this registry. Demographic characteristics, physical examination, clinical history, risk modification, lab assessment, and ASCVD risk score at presentation and at every follow-up will be recorded using a structural questionnaire.
Data Analysis Procedure: The Tentative analysis plan uses collected data for research publications. The statistical package for social sciences (SPSS 21) will be used to analyze baseline characteristics. The Shapiro-Wilk test will be applied to check the hypothesis of normality for quantitative (continuous) variables. Descriptive statistics such as mean ± SD, median (IQR), skewness, maximum, and minimum will be calculated for quantitative (continuous) variables. Frequency and percentages will be calculated for categorical variables.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Dr Rubina Rauf
- Phone Number: +923002947117
- Email: drrubinarauf@gmail.com
Study Contact Backup
- Name: Musa Karim
- Phone Number: +923323646169
- Email: mkarim.nicvd@gmail.com
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan, 75510
- Recruiting
- National Institute of Cardiovascular Diseases
-
Contact:
- Dr Rubina Rauf
- Phone Number: +923002947117
- Email: drrubinarauf@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All individuals attending the preventive cardiology clinics.
Exclusion Criteria:
- • Individuals who refused to give consent.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adult patients
Adult patients with or without cardiovascular diseases.
|
ASCVD Score and WHO Cardiovascular Risk score.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cardiovascular risk assesesment
Time Frame: Ten years
|
risk stratification of Cardiovascular diseases (CVD) in patients without established CVD but with CVD co morbids.we
are using Atherosclerotic Cardiovascular Diseases (ASCVD) Risk Score and World Heart Organization(WHO) Risk Score for CVD Risk Assesment.
In ASCVD Risk Score, we categorize population into low risk ( score <5), borderline(score between 5 and 7.4) ,intermediate( score between 7.5 an 19.9) and high risk (score>20), using all parameters for risk assesment.
For WHO risk score calculation we are using WHO Risk score system for South Asia.
https://cdn.who.int/media/docs/default-source/cardiovascular-diseases/south-asia.pdf?sfvrsn=c5b0d9a3_2
|
Ten years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiovascular risk reduction
Time Frame: Ten years
|
CVD risk reduction in patients with or without established CVD but with CVD co morbids.
|
Ten years
|
|
Cardiovascular related deaths
Time Frame: Ten years.
|
Estimation of patients who expired in their follow up despite CVD risk factors management.
|
Ten years.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dr Rubina Rauf, National Institute of Cardiovascular Diseases
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB-20/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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