NCT07662161

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
384

participants targeted

Target at P75+ for all trials

Timeline
48mo left

Started Jul 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jul 2026Jul 2030

First Submitted

Initial submission to the registry

June 14, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 23, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

June 23, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 14, 2026

Last Update Submit

June 18, 2026

Conditions

Keywords

coronary calciumcoronary calcificationcardiovascular riskmajor adverse cardiovascular events

Outcome Measures

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.

    Baseline

Secondary Outcomes (2)

  • Cardiovascular risk

    Baseline

  • Major adverse cardiovascular events

    Through study completion, an average of 4 years.

Study Arms (1)

Diagnosed with HIV

more than 6 months since being diagnosed with HIV

Diagnostic Test: Simple coronary CT scan

Interventions

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

Diagnosed with HIV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients who have been diagnosed with HIV infection for more than 6 months
  • Undetectable viral load

You may not qualify if:

  • Patients who have previously taken statins
  • Patients with chronic ischemic heart disease that has required stenting or revascularization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Mexicano del Seguro Social

León, Guanajuato, 37320, Mexico

Location

Related Publications (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Central Study Contacts

Hilda E. Macias-Cervantes, PhD

CONTACT

Irma N. Rocha-Salazar, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 14, 2026

First Posted

June 23, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

July 1, 2030

Last Updated

June 23, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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

Locations