HIV - Human Immunodeficiency VirusCACsHIVMexNCT07662161
Coronary Artery Calcium Score in HIV Mexican Population (The CACsHIVMex Study)
An observational study of HIV - Human Immunodeficiency Virus, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV - Human Immunodeficiency Virus
- What is being tested?
- Simple coronary CT scan
- How many people
- 384 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jul 2026to Jul 2030
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients who have been diagnosed with HIV infection for more than 6 months
- Undetectable viral load
Who cannot join
- Patients who have previously taken statins
- Patients with chronic ischemic heart disease that has required stenting or revascularization
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Instituto Mexicano del Seguro Social
León, Guanajuato, 37320
Hilda E. Macías-Cervantes, PhD, +55 477 717 4800, hildamacer@gmail.com
About this 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.
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.
- Conditions
- HIV - Human Immunodeficiency Virus
- Being tested
- Simple coronary CT scan
- Keywords
- coronary calcium, coronary calcification, cardiovascular risk, major adverse cardiovascular events
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple coronary CT scanDiagnostic test
All patients will undergo a standard coronary CT scan to measure coronary calcium
| Study group | Role | What they receive |
|---|---|---|
| Diagnosed with HIV | more than 6 months since being diagnosed with HIV Receives: Diagnostic Test: Simple coronary CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (2)
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
Measured: Baseline
Major adverse cardiovascular events
The occurrence of major adverse cardiovascular events will be assessed: acute myocardial infarction, stroke, and cardiovascular death
Measured: Through study completion, an average of 4 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV - Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 384 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hilda Elizabeth Macías Cervantes, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662161
- Sponsor's protocol ID
- 5
- Acronym
- CACsHIVMex
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because of the observational nature of the study, it will not be necessary.
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 26970999Raggi 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 18582630Graham 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 23078882Suzuki 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 40199704Shah 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Artery Calcium Score in HIV Mexican Population (The CACsHIVMex Study)
- ClinicalTrials.gov ID
- NCT07662161
- Acronym / sponsor ID
- CACsHIVMex / 5
- Conditions
- HIV - Human Immunodeficiency Virus
- Keywords
- coronary calcium, coronary calcification, cardiovascular risk, major adverse cardiovascular events
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosed with HIV | – | Diagnostic Test: Simple coronary CT scanmore than 6 months since being diagnosed with HIV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients who have been diagnosed with HIV infection for more than 6 months
- Undetectable viral load
Key exclusion criteria (2 listed)
- Patients who have previously taken statins
- Patients with chronic ischemic heart disease that has required stenting or revascularization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simple coronary CT scanAll patients will undergo a standard coronary CT scan to measure coronary calcium | Diagnostic test | Diagnosed with HIV |
Primary outcome
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.
2 secondary outcomes
Cardiovascular risk
Time frame: Baseline
Major adverse cardiovascular events
Time frame: Through study completion, an average of 4 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Results publication: PubMed 26970999Handy 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.
- Results publication: PubMed 18582630Raggi 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.
- Results publication: PubMed 23078882Graham 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.
- Results publication: PubMed 40199704Suzuki 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.
- Results publication: PubMed 29967196Shah 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.
- Individual participant dataSharing planned: No. Because of the observational nature of the study, it will not be necessary.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV - Human Immunodeficiency Virus, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hilda E. Macias-Cervantes, PhD (+55 477 717 4800, hildamacer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary calcium (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07662161, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.