Prospective Assessment of Atherosclerotic Cardiovascular Disease (ASCVD) Risk

NCT06316453 | Recruiting

• 1 other identifier: PARADISE-PK-09-03-2024
• Study Type: observational
• Target: 3,513
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to conduct a 10-year follow-up to assess ASCVD risk in Pakistan among individuals aged 30 years and above without a known history of ASCVD. The focus will be on evaluating ASCVD risk over this specific 10-year timeframe. The study will also validate risk assessment scores for identifying high-risk individuals and examine the incidence rate of ASCVD events during long-term follow-up.

Conditions

Atherosclerotic Cardiovascular Diseases (ASCVD)

Keywords

Prospective; Atherosclerotic Cardiovascular Disease (ASCVD); Risk; Pakistan; Management Strategies

Outcome Measures

Primary Outcomes (4)

• 10-year ASCVD risk Categorization

  Participants will be stratified into distinct 10-year ASCVD risk categories, including low risk (\<5%), borderline risk (5% to \<7.5%), intermediate risk (7.5% to \<20%), or high risk (≥20%).

  3 Months

• 30-year ASCVD risk Categorization

  The 30-year ASCVD risk assessment will utilize the formula proposed by Pencina MJ, classifying participants based on their risk for "hard" and "general" CVD events.

  3 Months

• Lifetime ASCVD risk evaluation

  The lifetime ASCVD risk evaluation will categorize individuals into risk groups, distinguishing between optimal, not optimal, elevated, and major risk factors, determined by specific risk criteria.

  3 Months

• Genetic Risk Assessment of ApoB

  For Genetic Risk Assessment of ApoB, the study will compute the Genetic Risk Score (GRS) based on genotyping the APOB rs1042031 variant, following the methodology outlined by Shahid SU. The unweighted GRS for ApoB will be derived through an additive approach, assigning values of 0, 1, and 2 for protective homozygous, heterozygous, and risk homozygous genotypes, respectively. This resulting GRS for ApoB will range from 0 (indicating the absence of risk alleles) to 2 (both alleles identified as risk alleles for APOB rs1042031) in an individual.

  3 Months

Study Arms (1)

Non pre-existing ASCVD

ASCVD risk in adults will be assessed alongside demographics and clinical history. The study will calculate 10-year, 30-year, and lifetime ASCVD risks, incorporating genetic assessment for Apo B. Personalized management recommendations based on ASCVD risk will be provided, and a six-month follow-up will track ASCVD events.

Other: Evaluating ASCVD risk over 10 and 30 year and lifetime

Interventions

Evaluating ASCVD risk over 10 and 30 year and lifetime OTHER

Utilizing validated tools such as the Pooled Cohort Equations (PCE) for 10-year ASCVD risk, the 30-year ASCVD risk prediction tool, and lifetime ASCVD risk categories, participants will undergo a thorough risk assessment. This multi-dimensional approach ensures a nuanced understanding of short and long-term cardiovascular risks. Further, The genetic risk for ApoB will be meticulously assessed by genotyping the APOB rs1042031 variant. Subsequently, the calculation of the genetic risk score (GRS) based on risk alleles will provide personalized insight into genetic predispositions related to ASCVD risk. Moreover, Participants will receive personalized management recommendations derived from the ACC/AHA Cardiovascular Risk Assessment Guidelines. These tailored suggestions may encompass dietary programs, lifestyle modifications, and, when indicated, pharmaceutical therapies like statins, aiming to mitigate identified risks effectively

Non pre-existing ASCVD

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The sample size, determined by insights from a study by An J, which showcased a median 10-year ASCVD risk of 0.6% in a sizable sample of 414,260 young adults, has been rigorously calculated. To enhance the robustness of our study and account for potential observational bias and missing clinical characteristics, the initially identified sample size has been increased by a factor of 1.5. This adjustment ensures a more comprehensive representation, resulting in a final sample size of 3,513 individuals, specifically young and healthy participants. To accurately reflect the diverse population across Pakistan, stratification based on the 2017 census data will be employed, ensuring representation from all four provinces and optimizing the study's applicability and generalizability.

You may qualify if:

• Individuals of any gender
• Individuals aged 30 years and above
• The study ensured a diverse representation to encompass a broad spectrum of experiences and risk factors within this age group
• Individuals without pre-existing cardiovascular conditions

You may not qualify if:

• Individuals with a confirmed diagnosis of ASCVD
• Confirmed cases of cancer
• participants who express a refusal to provide informed consent

Sponsors & Collaborators

• Advanced Education & Research Center: lead
• University of Karachi: collaborator
• Pakistan Cardiac Society (Heart House): collaborator

Study Sites (1)

Advanced Education Institute and Research Center

Karachi, Sindh, 75270, Pakistan

RECRUITING

Related Publications (24)

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MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tariq Ashraf

  National Institute of Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sadaf Ahmed, PhD

CONTACT

03333061127; sadaf@aeirc-edu.com

Shamoon Noushad

CONTACT

03333549258

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 18, 2024
• Study Start: January 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)