ClinicalTrials.gg
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.

Primary conditionAcquired Immunodeficiency Syndrome(the registry's first term)UnverifiedIs this wrong?The registry often attaches Acquired Immunodeficiency Syndrome to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by Instituto Mexicano del Seguro Social · Observational

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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

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Keywords

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

In context

Acquired Immunodeficiency Syndrome Unverified

3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.

This study's planned enrollment of 384 is above the median of 289 across 504 observational studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

Instituto Mexicano del Seguro Social is the lead sponsor of 126 studies on the registry; 21 are open to participants now.

Compared within Acquired Immunodeficiency Syndrome, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients who have been diagnosed with 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

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

06

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.

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Study locations

1 site
  • Instituto Mexicano del Seguro Social
    León, Guanajuato 37320, Mexico
08

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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2026; primary completion for Dec 2026, 5 months later.

Of 165 non-industry observational studies under Acquired Immunodeficiency Syndrome, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 83. This study's planned 5 months is below that.

Counting every sponsor, half of 177 studies reached it within 44 months; a quarter within 19 and three quarters within 79.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 14, 2026
First posted
Jun 23, 2026
StartEst.
Jul 1, 2026
Primary completionEst.
Dec 30, 2026
CompletionEst.
Jul 2030
Last update
Jun 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07662161
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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Discussion

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