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Not yet recruiting NCT07662161

Coronary Artery Calcium Score in HIV Mexican Population (The CACsHIVMex Study)

— Observational HIV - Human Immunodeficiency Virus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Simple coronary CT scan.
Who it may be relevant to
Registry conditions: HIV - Human Immunodeficiency Virus. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Mexico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The risk of atherosclerotic cardiovascular disease is increased in people with HIV infection, including young patients and those with few traditional cardiovascular risk factors. The increased risk of cardiovascular disease among people living with HIV is due to accelerated atherosclerosis, caused by chronic inflammation and immune dysregulation. The measurement of coronary calcium using plain computed tomography is a subclinical indicator of coronary atherosclerosis and is associated with the risk of cardiovascular events and mortality in the general population.

Detailed description

Therefore, the primary objective is to assess the coronary calcium score in patients with chronic retroviral infection using plain coronary CT scan. In addition to correlating coronary calcium scores with patients' clinical and biochemical variables, and determining whether the coronary calcium score influences patients' subsequent treatment.

Interventions

  • Diagnostic test Simple coronary CT scan
    All patients will undergo a standard coronary CT scan to measure coronary calcium

Primary outcome measures

  • Coronary calcium [Time frame: Baseline]
Secondary outcome measures (2)
  • Cardiovascular risk [Time frame: Baseline]
  • Major adverse cardiovascular events [Time frame: Through study completion, an average of 4 years.]

Eligibility criteria

Inclusion criteria

  • Patients who have been diagnosed with HIV infection for more than 6 months
  • Undetectable viral load

Exclusion criteria

  • Patients who have previously taken statins
  • Patients with chronic ischemic heart disease that has required stenting or revascularization

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Mexico · 1 center
  • Instituto Mexicano del Seguro Social — León

Publications

  • Handy CE, Desai CS, Dardari ZA, Al-Mallah MH, Miedema MD, Ouyang P, Budoff MJ, Blumenthal RS, Nasir K, Blaha MJ. The Association of Coronary Artery Calcium With Noncardiovascular Disease: The Multi-Ethnic Study of Atherosclerosis. JACC Cardiovasc Imaging. 2016 May;9(5):568-576. doi: 10.1016/j.jcmg.2015.09.020. Epub 2016 Mar 9. PMID 26970999
  • Raggi P, Gongora MC, Gopal A, Callister TQ, Budoff M, Shaw LJ. Coronary artery calcium to predict all-cause mortality in elderly men and women. J Am Coll Cardiol. 2008 Jul 1;52(1):17-23. doi: 10.1016/j.jacc.2008.04.004. PMID 18582630
  • Graham G, Blaha MJ, Budoff MJ, Rivera JJ, Agatston A, Raggi P, Shaw LJ, Berman D, Rana JS, Callister T, Rumberger JA, Min J, Blumenthal RS, Nasir K. Impact of coronary artery calcification on all-cause mortality in individuals with and without hypertension. Atherosclerosis. 2012 Dec;225(2):432-7. doi: 10.1016/j.atherosclerosis.2012.08.014. Epub 2012 Sep 10. PMID 23078882
  • Suzuki T, Haberlen S, Peterson TE, Palella F, Budoff MJ, Witt MD, Magnani JW, Post WS. Coronary artery calcium and all-cause mortality in the Multicenter AIDS Cohort Study. Atherosclerosis. 2025 May;404:119181. doi: 10.1016/j.atherosclerosis.2025.119181. Epub 2025 Apr 2. PMID 40199704
  • Shah ASV, Stelzle D, Lee KK, Beck EJ, Alam S, Clifford S, Longenecker CT, Strachan F, Bagchi S, Whiteley W, Rajagopalan S, Kottilil S, Nair H, Newby DE, McAllister DA, Mills NL. Global Burden of Atherosclerotic Cardiovascular Disease in People Living With HIV: Systematic Review and Meta-Analysis. Circulation. 2018 Sep 11;138(11):1100-1112. doi: 10.1161/CIRCULATIONAHA.117.033369. PMID 29967196

Identifiers

NCT: NCT07662161 · 5

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗