Atherosclerotic Cardiovascular Diseases (ASCVD)NCT06316453
Prospective Assessment of Atherosclerotic Cardiovascular Disease (ASCVD) Risk
An observational study of Atherosclerotic Cardiovascular Diseases (ASCVD), run by Advanced Education & Research Center at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerotic Cardiovascular Diseases (ASCVD)
- What is being tested?
- Evaluating ASCVD risk over 10 and 30 year and lifetime
- How many people
- 3,513 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2024to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Individuals with a confirmed diagnosis of ASCVD
- Confirmed cases of cancer
- participants who express a refusal to provide informed consent
Trial locations and contacts
1 site in 1 country.
Shamoon Noushad contact
Pakistan1 site, 1 recruiting
- Recruiting
Advanced Education Institute and Research Center
Karachi, Sindh, 75270
Shamoon Noushad, 03333549258
About this study
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
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.
Read the 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.
- Being tested
- Evaluating ASCVD risk over 10 and 30 year and lifetime
- Keywords
- Prospective, Atherosclerotic Cardiovascular Disease (ASCVD), Risk, Pakistan, Management Strategies
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluating ASCVD risk over 10 and 30 year and lifetimeOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Evaluating ASCVD risk over 10 and 30 year and lifetime |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Jan 2024
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Atherosclerotic Cardiovascular Diseases (ASCVD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,513 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advanced Education & Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Karachi, Pakistan Cardiac Society (Heart House)
- Responsible party
- Sponsor
- Investigators
- Tariq Ashraf, Principal investigator, National Institute of Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316453
- Sponsor's protocol ID
- PARADISE-PK-09-03-2024
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mensah GA, Roth GA, Fuster V. The Global Burden of Cardiovascular Diseases and Risk Factors: 2020 and Beyond. J Am Coll Cardiol. 2019 Nov 19;74(20):2529-2532. doi: 10.1016/j.jacc.2019.10.009. No abstract available.
PubMed 31727292Connelly PJ, Azizi Z, Alipour P, Delles C, Pilote L, Raparelli V. The Importance of Gender to Understand Sex Differences in Cardiovascular Disease. Can J Cardiol. 2021 May;37(5):699-710. doi: 10.1016/j.cjca.2021.02.005. Epub 2021 Feb 13.
PubMed 33592281Wang T, Zhao Z, Yu X, Zeng T, Xu M, Xu Y, Hu R, Chen G, Su Q, Mu Y, Chen L, Tang X, Yan L, Qin G, Wan Q, Gao Z, Wang G, Shen F, Luo Z, Qin Y, Chen L, Huo Y, Li Q, Ye Z, Zhang Y, Liu C, Wang Y, Wu S, Yang T, Deng H, Zhao J, Xu Y, Li M, Chen Y, Wang S, Ning G, Bi Y, Shi L, Lu J, Wang W. Age-specific modifiable risk factor profiles for cardiovascular disease and all-cause mortality: a nationwide, population-based, prospective cohort study. Lancet Reg Health West Pac. 2021 Sep 26;17:100277. doi: 10.1016/j.lanwpc.2021.100277. eCollection 2021 Dec.
PubMed 35005664Zhao D. Epidemiological Features of Cardiovascular Disease in Asia. JACC Asia. 2021 Jun 15;1(1):1-13. doi: 10.1016/j.jacasi.2021.04.007. eCollection 2021 Jun.
PubMed 36338365Gheorghe A, Griffiths U, Murphy A, Legido-Quigley H, Lamptey P, Perel P. The economic burden of cardiovascular disease and hypertension in low- and middle-income countries: a systematic review. BMC Public Health. 2018 Aug 6;18(1):975. doi: 10.1186/s12889-018-5806-x.
PubMed 30081871Joseph P, Leong D, McKee M, Anand SS, Schwalm JD, Teo K, Mente A, Yusuf S. Reducing the Global Burden of Cardiovascular Disease, Part 1: The Epidemiology and Risk Factors. Circ Res. 2017 Sep 1;121(6):677-694. doi: 10.1161/CIRCRESAHA.117.308903.
PubMed 28860318Lu Y, Li SX, Liu Y, Rodriguez F, Watson KE, Dreyer RP, Khera R, Murugiah K, D'Onofrio G, Spatz ES, Nasir K, Masoudi FA, Krumholz HM. Sex-Specific Risk Factors Associated With First Acute Myocardial Infarction in Young Adults. JAMA Netw Open. 2022 May 2;5(5):e229953. doi: 10.1001/jamanetworkopen.2022.9953.
PubMed 35503221Cho KI, Shin ES, Ann SH, Garg S, Her AY, Kim JS, Han JH, Jeong MH; KAMIR Registry. Gender differences in risk factors and clinical outcomes in young patients with acute myocardial infarction. J Epidemiol Community Health. 2016 Nov;70(11):1057-1064. doi: 10.1136/jech-2015-207023. Epub 2016 May 4.
PubMed 27146351Batra MK, Rizvi NH, Sial JA, Saghir T, Karim M. Angiographic characteristics and in hospital outcome of young patients, age up to 40 versus more than 40 years undergoing primary percutaneous coronary intervention. J Pak Med Assoc. 2019 Sep;69(9):1308-1312.
PubMed 31511716Ullah W, Malik R, Bashir F, Khan M, Khan S, Alam M, Samad Z, Achirica MC, Virani SS, Hanif B. Comparison of Premature, Extremely Premature, and Older Adults With Coronary Artery Disease in Pakistan. JACC Asia. 2023 Jan 24;3(1):164-165. doi: 10.1016/j.jacasi.2022.10.002. eCollection 2023 Feb. No abstract available.
PubMed 36873748Studzinski K, Tomasik T, Krzyszton J, Jozwiak J, Windak A. Effect of using cardiovascular risk scoring in routine risk assessment in primary prevention of cardiovascular disease: an overview of systematic reviews. BMC Cardiovasc Disord. 2019 Jan 9;19(1):11. doi: 10.1186/s12872-018-0990-2.
PubMed 30626326Goff DC Jr, Lloyd-Jones DM, Bennett G, Coady S, D'Agostino RB, Gibbons R, Greenland P, Lackland DT, Levy D, O'Donnell CJ, Robinson JG, Schwartz JS, Shero ST, Smith SC Jr, Sorlie P, Stone NJ, Wilson PW, Jordan HS, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S49-73. doi: 10.1161/01.cir.0000437741.48606.98. Epub 2013 Nov 12. No abstract available.
PubMed 24222018Arnett DK, Blumenthal RS, Albert MA, Buroker AB, Goldberger ZD, Hahn EJ, Himmelfarb CD, Khera A, Lloyd-Jones D, McEvoy JW, Michos ED, Miedema MD, Munoz D, Smith SC Jr, Virani SS, Williams KA Sr, Yeboah J, Ziaeian B. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Sep 10;140(11):e596-e646. doi: 10.1161/CIR.0000000000000678. Epub 2019 Mar 17. No abstract available.
PubMed 30879355An J, Zhang Y, Zhou H, Zhou M, Safford MM, Muntner P, Moran AE, Reynolds K. Incidence of Atherosclerotic Cardiovascular Disease in Young Adults at Low Short-Term But High Long-Term Risk. J Am Coll Cardiol. 2023 Feb 21;81(7):623-632. doi: 10.1016/j.jacc.2022.11.051.
PubMed 36792277Lloyd-Jones DM, Braun LT, Ndumele CE, Smith SC Jr, Sperling LS, Virani SS, Blumenthal RS. Use of Risk Assessment Tools to Guide Decision-Making in the Primary Prevention of Atherosclerotic Cardiovascular Disease: A Special Report From the American Heart Association and American College of Cardiology. J Am Coll Cardiol. 2019 Jun 25;73(24):3153-3167. doi: 10.1016/j.jacc.2018.11.005. Epub 2018 Nov 10.
PubMed 30423392
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06316453
- Acronym / sponsor ID
- PARADISE-PK-09-03-2024
- Keywords
- Prospective, Atherosclerotic Cardiovascular Disease (ASCVD), Risk, Pakistan, Management Strategies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,513 participants (estimated)
- Lead sponsor
- Advanced Education & Research CenterUniversity, hospital or other
- Collaborators
- University of Karachi, Pakistan Cardiac Society (Heart House)
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non pre-existing ASCVD | – | Other: Evaluating ASCVD risk over 10 and 30 year and lifetimeASCVD 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. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Individuals with a confirmed diagnosis of ASCVD
- Confirmed cases of cancer
- participants who express a refusal to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluating ASCVD risk over 10 and 30 year and lifetimeUtilizing 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 | Other | Non pre-existing ASCVD |
Primary outcome
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%).
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Background: PubMed 31727292Mensah GA, Roth GA, Fuster V. The Global Burden of Cardiovascular Diseases and Risk Factors: 2020 and Beyond. J Am Coll Cardiol. 2019 Nov 19;74(20):2529-2532. doi: 10.1016/j.jacc.2019.10.009. No abstract available.
- Background: PubMed 33592281Connelly PJ, Azizi Z, Alipour P, Delles C, Pilote L, Raparelli V. The Importance of Gender to Understand Sex Differences in Cardiovascular Disease. Can J Cardiol. 2021 May;37(5):699-710. doi: 10.1016/j.cjca.2021.02.005. Epub 2021 Feb 13.
- Background: PubMed 35005664Wang T, Zhao Z, Yu X, Zeng T, Xu M, Xu Y, Hu R, Chen G, Su Q, Mu Y, Chen L, Tang X, Yan L, Qin G, Wan Q, Gao Z, Wang G, Shen F, Luo Z, Qin Y, Chen L, Huo Y, Li Q, Ye Z, Zhang Y, Liu C, Wang Y, Wu S, Yang T, Deng H, Zhao J, Xu Y, Li M, Chen Y, Wang S, Ning G, Bi Y, Shi L, Lu J, Wang W. Age-specific modifiable risk factor profiles for cardiovascular disease and all-cause mortality: a nationwide, population-based, prospective cohort study. Lancet Reg Health West Pac. 2021 Sep 26;17:100277. doi: 10.1016/j.lanwpc.2021.100277. eCollection 2021 Dec.
- Background: PubMed 36338365Zhao D. Epidemiological Features of Cardiovascular Disease in Asia. JACC Asia. 2021 Jun 15;1(1):1-13. doi: 10.1016/j.jacasi.2021.04.007. eCollection 2021 Jun.
- Background: PubMed 30081871Gheorghe A, Griffiths U, Murphy A, Legido-Quigley H, Lamptey P, Perel P. The economic burden of cardiovascular disease and hypertension in low- and middle-income countries: a systematic review. BMC Public Health. 2018 Aug 6;18(1):975. doi: 10.1186/s12889-018-5806-x.
- Background: PubMed 28860318Joseph P, Leong D, McKee M, Anand SS, Schwalm JD, Teo K, Mente A, Yusuf S. Reducing the Global Burden of Cardiovascular Disease, Part 1: The Epidemiology and Risk Factors. Circ Res. 2017 Sep 1;121(6):677-694. doi: 10.1161/CIRCRESAHA.117.308903.
- Background: PubMed 35503221Lu Y, Li SX, Liu Y, Rodriguez F, Watson KE, Dreyer RP, Khera R, Murugiah K, D'Onofrio G, Spatz ES, Nasir K, Masoudi FA, Krumholz HM. Sex-Specific Risk Factors Associated With First Acute Myocardial Infarction in Young Adults. JAMA Netw Open. 2022 May 2;5(5):e229953. doi: 10.1001/jamanetworkopen.2022.9953.
- Background: PubMed 27146351Cho KI, Shin ES, Ann SH, Garg S, Her AY, Kim JS, Han JH, Jeong MH; KAMIR Registry. Gender differences in risk factors and clinical outcomes in young patients with acute myocardial infarction. J Epidemiol Community Health. 2016 Nov;70(11):1057-1064. doi: 10.1136/jech-2015-207023. Epub 2016 May 4.
- Background: PubMed 31511716Batra MK, Rizvi NH, Sial JA, Saghir T, Karim M. Angiographic characteristics and in hospital outcome of young patients, age up to 40 versus more than 40 years undergoing primary percutaneous coronary intervention. J Pak Med Assoc. 2019 Sep;69(9):1308-1312.
- Background: PubMed 36873748Ullah W, Malik R, Bashir F, Khan M, Khan S, Alam M, Samad Z, Achirica MC, Virani SS, Hanif B. Comparison of Premature, Extremely Premature, and Older Adults With Coronary Artery Disease in Pakistan. JACC Asia. 2023 Jan 24;3(1):164-165. doi: 10.1016/j.jacasi.2022.10.002. eCollection 2023 Feb. No abstract available.
- Background: PubMed 30626326Studzinski K, Tomasik T, Krzyszton J, Jozwiak J, Windak A. Effect of using cardiovascular risk scoring in routine risk assessment in primary prevention of cardiovascular disease: an overview of systematic reviews. BMC Cardiovasc Disord. 2019 Jan 9;19(1):11. doi: 10.1186/s12872-018-0990-2.
- Background: PubMed 24222018Goff DC Jr, Lloyd-Jones DM, Bennett G, Coady S, D'Agostino RB, Gibbons R, Greenland P, Lackland DT, Levy D, O'Donnell CJ, Robinson JG, Schwartz JS, Shero ST, Smith SC Jr, Sorlie P, Stone NJ, Wilson PW, Jordan HS, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S49-73. doi: 10.1161/01.cir.0000437741.48606.98. Epub 2013 Nov 12. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shamoon Noushad contact
Tariq Ashraf principal investigator
National Institute of Cardiovascular Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerotic Cardiovascular Diseases (ASCVD), run by Advanced Education & Research Center at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sadaf Ahmed, PhD (03333061127, sadaf@aeirc-edu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10-year ASCVD risk Categorization (time frame: 3 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06316453, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.