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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstituto Mexicano del Seguro Social

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who have been diagnosed with HIV infection for more than 6 months

Undetectable viral load

Disqualifiers

Patients who have previously taken statins

Patients with chronic ischemic heart disease that has required stenting or revascularization

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Simple coronary CT scan

    Diagnostic test

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

Treatment groups

384 Participants
are divided into 1 treatment group
Group A: Diagnosed with HIV1 intervention

Trial outcomes

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.

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: