A Hospital-Based Registry of Preventive Cardiology Clinics

Recruiting

• Conditions: Cardiovascular Risk Assesment; Primary Prevention CVD; Cardiovascular Morbidity
• Interventions: Other: Cardiovascular risk assesment

• Registration Number: NCT06503341
• Lead Sponsor: National Institute of Cardiovascular Diseases, Pakistan

Brief Summary

More research is needed to articulate the most effective ways to use these tools as screening tests in cardiovascular risk assessments and how they ultimately affect CVD mortality and morbidity outcomes. Clinicians are encouraged to continue sharing decision-making with patients to combine their unique cardiovascular risk factors and develop a comprehensive, effective treatment plan.

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 Timeline

• Study Start: 2021-06-17
• Status Verified: 2024-07
• Study First Submitted: 2024-07-09
• Study First Submitted QC: 2024-07-09
• Study First Posted: 2024-07-16
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-24
• Primary Completion: 2031-06
• Study Completion: 2041-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• All individuals attending the preventive cardiology clinics.

Exclusion Criteria

• • Individuals who refused to give consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult patients	Cardiovascular risk assesment	Adult patients with or without cardiovascular diseases.

Primary Outcome Measures

Name	Time	Method
cardiovascular risk assesesment	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

Secondary Outcome Measures

Name	Time	Method
Cardiovascular risk reduction	Ten years	CVD risk reduction in patients with or without established CVD but with CVD co morbids.
Cardiovascular related deaths	Ten years.	Estimation of patients who expired in their follow up despite CVD risk factors management.

Trial Locations

Locations (1)

National Institute of Cardiovascular Diseases; 🇵🇰 Karachi, Sindh, Pakistan