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NCT Number: NCT07662161

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

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.

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Key information

Conditions

HIV - Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simple coronary CT scan

Diagnostic Test

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Hilda E. Macias-Cervantes, PhD

CONTACT

[email protected]

+55 477 717 4800

Irma N. Rocha-Salazar, MD

CONTACT

[email protected]

+55 477 717 4800

Sponsors and collaborators

Lead sponsor

Instituto Mexicano del Seguro Social

Other Gov

Registry information

Acronym: CACsHIVMex

Important dates

Study start
2026
Primary completion
2026
Study completion
2030
First posted
Jun 23, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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