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Prospective Assessment of Atherosclerotic Cardiovascular Disease (ASCVD) Risk

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06316453
Enrollment
3513
Registered
2024-03-18
Start date
2024-01-01
Completion date
2024-12-31
Last updated
2024-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerotic Cardiovascular Diseases (ASCVD)

Keywords

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

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.

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.

Interventions

OTHEREvaluating 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

Sponsors

University of Karachi
CollaboratorOTHER
Pakistan Cardiac Society (Heart House)
CollaboratorUNKNOWN
Advanced Education & Research Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
10-year ASCVD risk Categorization3 MonthsParticipants 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%).
30-year ASCVD risk Categorization3 MonthsThe 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.
Lifetime ASCVD risk evaluation3 MonthsThe 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.
Genetic Risk Assessment of ApoB3 MonthsFor 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.

Countries

Pakistan

Contacts

Primary ContactSadaf Ahmed, PhD
sadaf@aeirc-edu.com03333061127
Backup ContactShamoon Noushad
03333549258

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026