Prospective Assessment of Atherosclerotic Cardiovascular Disease (ASCVD) Risk

March 26, 2024 updated by: Advanced Education & Research Center

Prospective Assessment of Atherosclerotic Cardiovascular Disease (ASCVD) Risk in Adults (30 Years and Above) in Pakistan: A Multi-Year Study Investigating Incidence, Validation, and Management Strategies

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cardiovascular diseases (CVD) pose a formidable challenge as the leading cause of premature mortality globally, affecting diverse populations across income societies. The dynamic interplay of sex and age significantly influences the trajectory and prognosis of atherosclerotic cardiovascular diseases (ASCVD). Previously perceived as an ailment predominantly afflicting affluent older men, ASCVD has undergone a transformative shift, emerging as an epidemic impacting the productivity of both young men and women. This resonance is particularly pronounced in communities with varying economic backgrounds, including high-income and low-to-middle-income settings. The far-reaching consequences of premature CVD extend beyond the individual, exerting socioeconomic strains on families and societies, especially in lower-income communities. Recognizing the gravity of this situation, the World Health Organization (WHO) initiated the "25 by 25" campaign, aiming to curtail premature mortality from non-communicable diseases, with over 60% attributed to CVD, by 25% before 2025.

While global data on gender- and age-specific variations in CVD risk factors and outcomes have been extensively documented, the local evidence in Pakistan underscores a crucial research gap. A contemporary ST-elevation acute coronary syndrome (STE-ACS) cohort in Pakistan reveals a noteworthy 12% of premature cases (<40 years). A study by Ullah W et al., comprising 15,106 participants from the Cardiac Registry of Pakistan Catheterization Percutaneous Coronary Intervention, reports 7.4% of patients under 40 years. However, comprehensive local evidence on the incidence of ASCVD among the young population remains scarce.

Current risk assessment guidelines, exemplified by the 2019 ACC/AHA Cardiovascular Risk Assessment Guidelines, predominantly employ race- and sex-specific Pooled Cohort Equations (PCE) for predicting 10-year CVD risk, specifically in adults aged 40 to 75. However, these guidelines need more direct applicability to young adults, who often exhibit a paradox of low 10-year ASCVD predicted risk despite harboring a high lifetime risk profile. Acknowledging this discrepancy, the 2018 AHA/ACC cholesterol guideline advocates for estimating lifetime or 30-year ASCVD risk for individuals under 40.

Transitioning from risk assessment to lipid modulation, mainly focusing on low-density lipoproteins (LDL), unveils a pivotal role in atherogenesis. LDL assumes primary responsibility in cholesterol transport. The strategic modulation of lipid profiles has emerged as a central goal for cardiovascular prevention, concentrated on mitigating cardiovascular risk through targeted reduction of LDL-cholesterol using diverse lipid-lowering agents. Recent attention has shifted towards compounds offering nuanced insights into pro-atherogenic risk, with apolipoproteins playing an essential role in regulating lipoprotein metabolism and garnering significant attention in atherosclerosis.

Among the various apolipoproteins, apolipoprotein B (Apo B) emerges as a crucial component integral to all atherogenic lipids, including very low-density lipoproteins (VLDLs), intermediate-density lipoproteins (IDLs), LDLs, and chylomicrons. Existing literature underscores substantial variability in the lipid composition of Apo B lipoproteins, positioning Apo B as superior to total cholesterol and triglyceride levels in predicting cardiovascular risk. However, the predictive role of Apo B versus LDL-cholesterol remains controversial. While some studies advocate for Apo B as a more precise predictor of cardiovascular risk than LDL-cholesterol and non-high-density lipoprotein cholesterol (non-HDL), a recent extensive study involving over 300,000 patients did not establish the superiority of Apo B over LDL-cholesterol in assessing cardiovascular risk. This divergence in findings is mirrored in the 2021 ESC Guidelines on Cardiovascular Disease Prevention in Clinical Practice. Consequently, a series of comprehensive studies is imperative to delineate the precise role of Apo B as a predictor of cardiovascular diseases (CVDs).

In light of Pakistan's escalating ASCVD burden, early identification and optimal management of modifiable risk factors become imperative for prevention. While conclusive studies are lacking, expert recommendations underscore the utility of "total/absolute CVD risk" assessment in guiding management decisions. This study, utilizing the ASCVD risk score and WHO risk score system, aims to evaluate ASCVD risk in young individuals, categorizing risks into low, intermediate, and high groups to guide tailored interventions, be it lifestyle modifications, non-pharmaceutical management, or pharmaceutical interventions, at each specific stage.

Study Type

Observational

Enrollment (Estimated)

3513

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Shamoon Noushad
  • Phone Number: 03333549258

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75270
        • Recruiting
        • Advanced Education Institute and Research Center
        • Contact:
          • Shamoon Noushad
          • Phone Number: 03333549258

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
10-year ASCVD risk Categorization
Time Frame: 3 Months
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
Time Frame: 3 Months
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
Time Frame: 3 Months
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
Time Frame: 3 Months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advanced Education & Research Center

Collaborators

University of Karachi
Pakistan Cardiac Society (Heart House)

Investigators

  • Principal Investigator: Tariq Ashraf, National Institute of CardioVascular Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PARADISE-PK-09-03-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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