Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06316453
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-03-12
Brief Title:
Prospective Assessment of Atherosclerotic Cardiovascular Disease ASCVD Risk
Sponsor:
Advanced Education Research Center
Organization:
Advanced Education Research Center
Study Overview
Official Title:
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
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 15106 participants from the Cardiac Registry of Pakistan Catheterization Percutaneous Coronary Intervention reports 74 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 ACCAHA 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 AHAACC 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 300000 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 Pakistans 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 totalabsolute 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
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 15106 participants from the Cardiac Registry of Pakistan Catheterization Percutaneous Coronary Intervention reports 74 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 ACCAHA 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 AHAACC 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 300000 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 Pakistans 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 totalabsolute 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None