Clinical trial NCT06503341: A Hospital-Based Registry of Preventive Cardiology Clinics
Official title: Assessment and Control of Modifiable Risk Factors for Primary and Secondary Prevention
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Morbidity
Cardiovascular Risk Assesment
Primary Prevention CVD
Lead sponsor: National Institute of Cardiovascular Diseases, Pakistan
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both genders, age 18 and above, visiting preventive cardiology clinics with or without established CVD and may or may not have CVD risk factors.

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.

Eligibility criteria: Inclusion Criteria:

* All individuals attending the preventive cardiology clinics.

Exclusion Criteria:

* • Individuals who refused to give consent.

Primary outcomes:
measure: cardiovascular risk assesesment
timeFrame: Ten years
Secondary outcomes:
measure: Cardiovascular risk reduction
timeFrame: Ten years
measure: Cardiovascular related deaths
timeFrame: Ten years.
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: National Institute of Cardiovascular Diseases
state: Sindh
Study officials:
affiliation: National Institute of Cardiovascular Diseases
name: Dr Rubina Rauf
role: PRINCIPAL_INVESTIGATOR
References: