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

June 18, 2026 updated by: Hilda Elizabeth Macías Cervantes, Instituto Mexicano del Seguro Social
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

384

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Guanajuato
      • León, Guanajuato, Mexico, 37320
        • Instituto Mexicano del Seguro Social
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diagnosed with HIV
more than 6 months since being diagnosed with HIV
Diagnostic test: Simple coronary CT scan
All patients will undergo a standard coronary CT scan to measure coronary calcium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coronary calcium
Time Frame: Baseline

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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular risk
Time Frame: Baseline

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
Baseline
Major adverse cardiovascular events
Time Frame: Through study completion, an average of 4 years.
The occurrence of major adverse cardiovascular events will be assessed: acute myocardial infarction, stroke, and cardiovascular death
Through study completion, an average of 4 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Mexicano del Seguro Social

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

July 1, 2030

Study Registration Dates

First Submitted

June 14, 2026

First Submitted That Met QC Criteria

June 18, 2026

First Posted (Actual)

June 23, 2026

Study Record Updates

Last Update Posted (Actual)

June 23, 2026

Last Update Submitted That Met QC Criteria

June 18, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Because of the observational nature of the study, it will not be necessary.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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