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Not yet recruitingNCT07662161CACsHIVMexUpdated Jun 23, 2026

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

An observational study in HIV - Human Immunodeficiency Virus, sponsored by Instituto Mexicano del Seguro Social. Not yet recruiting at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-23.

Sponsored by Instituto Mexicano del Seguro Social · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
384
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • HIV - Human Immunodeficiency Virus

Keywords

  • coronary calcium
  • coronary calcification
  • cardiovascular risk
  • major adverse cardiovascular events
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

A multicenter study that will include patients diagnosed with HIV from three hospitals in León: the Mexican Social Security Institute (2) and CAPASITS León.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients who have previously taken statins
  • Patients with chronic ischemic heart disease that has required stenting or revascularization
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
384 participants (estimated)
Target follow-up
4 Years
Patient registry
Yes

Groups and cohorts

  • Diagnosed with HIV

    more than 6 months since being diagnosed with HIV

    Diagnostic Test: Simple coronary CT scan

Interventions

  • Diagnostic testSimple coronary CT scan

    All patients will undergo a standard coronary CT scan to measure coronary calcium

05

What researchers measure

Primary outcomes

  1. Coronary calcium

    The result is expressed in points using the Agatston scale and indicates the level of risk: * 0 points: No calcium. Very low risk. No significant coronary artery disease apparent at the time of the study. * 1 to 99 points: Mild calcified plaque. There is a mild risk of heart disease. * 100 to 300 points: Moderate plaque. Moderate risk of heart disease. * More than 300 points: Extensive plaque. High risk of heart disease and heart attack.

    Time frame: Baseline

Secondary outcomes

  1. Cardiovascular risk

    For every patient who meets the inclusion criteria, cardiovascular risk will be assessed using the Predicting Risk of Cardiovascular Disease EVENTs (PREVENT) equations estimate 10-year and 30-year risk for total cardiovascular disease (CVD), including atherosclerotic CVD (ASCVD) and heart failure. It is classified as follows: * Low risk: Less than 5% * Borderline risk: 5% to 7.4% * Intermediate risk: 7.5% to 19.9% * High risk: 20% or more

    Time frame: Baseline

  2. Major adverse cardiovascular events

    The occurrence of major adverse cardiovascular events will be assessed: acute myocardial infarction, stroke, and cardiovascular death

    Time frame: Through study completion, an average of 4 years.

06

Study locations

1 site
  • Instituto Mexicano del Seguro Social
    León, Guanajuato 37320, Mexico
07

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 29967196 ↗

Individual participant data

Plan to share: No — Because of the observational nature of the study, it will not be necessary.

08

Registry details

Key details

Study ID
NCT07662161
Lead sponsor
Instituto Mexicano del Seguro Social
Responsible party
Hilda Elizabeth Macías Cervantes (Principal Investigator, Instituto Mexicano del Seguro Social) — Principal investigator
First posted
Jun 23, 2026
Start date
Jul 1, 2026 (estimated)
Primary completion
Dec 30, 2026 (estimated)
Completion
Jul 2030 (estimated)
Last update
Jun 23, 2026

Study contacts

Hilda E. Macias-Cervantes, PhD
Contact
hildamacer@gmail.com
+55 477 717 4800
Irma N. Rocha-Salazar, MD
Contact
nohemi.slz@hotmail.com
+55 477 717 4800

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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