NCT07461350

Brief Summary

This observational research study is studying how substance use impacts scarring and inflammation of the heart. This study involves one study visit for a cardiac MRI.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
47mo left

Started Mar 2026

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

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 Progress5%
Mar 2026Mar 2030

First Submitted

Initial submission to the registry

February 20, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2030

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

4 years

First QC Date

February 20, 2026

Last Update Submit

March 4, 2026

Conditions

HIV (Human Immunodeficiency Virus)

Keywords

HIVcardiac MRIstimulant use

Outcome Measures

Primary Outcomes (1)

  • Cardiac MRI

    CMR assessments to provide detailed myocardial characterization (e.g. diffuse inflammation (nT1), myocardial fibrosis (ECV), and myocardial scar assessed using LGE)

    Visit 1, up to 2 hours

Study Arms (3)

Current Stimulant Use

Used stimulants (amphetamines, cocaine, etc.) in past year

Past Stimulant Use

Previously used stimulants (amphetamines, cocaine, etc.) but not in the last 12 months

No Stimulant use

Never used stimulants (amphetamines, cocaine, etc.)

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with and without HIV enrolled in the MACS/WIHS Combined Cohort Study (MWCCS) Atlanta, Baltimore, Bronx, and San Francisco study sites

You may qualify if:

  • \- Participants with and without HIV enrolled in the MACS/WIHS Combined Cohort Study (MWCCS) Atlanta, Baltimore, Bronx, and San Francisco study sites

You may not qualify if:

  • Standard contraindications to MRI
  • claustrophobia,
  • metal implants,
  • large body size (weight \>350 lbs or abdominal sagittal diameter \>70 cm),
  • pregnancy)
  • Gadolinium risk
  • severe or uncontrolled asthma,
  • visit day eGFR\<45 ml/min/1.73 m2;
  • poor venous access
  • pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

Emory University, School of Medicine

Atlanta, Georgia, 30322, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

Albert Einstein College of Medicine

The Bronx, New York, 10462, United States

Location

Related Publications (2)

  • Riley ED, Vittinghoff E, Wu AHB, Coffin PO, Hsue PY, Kazi DS, Wade A, Braun C, Lynch KL. Impact of polysubstance use on high-sensitivity cardiac troponin I over time in homeless and unstably housed women. Drug Alcohol Depend. 2020 Dec 1;217:108252. doi: 10.1016/j.drugalcdep.2020.108252. Epub 2020 Aug 30.

    PMID: 32919207BACKGROUND

  • Riley ED, Kizer JR, Tien PC, Vittinghoff E, Lynch KL, Wu AHB, Coffin PO, Beck-Engeser G, Braun C, Hunt PW. Multiple substance use, inflammation and cardiac stretch in women living with HIV. Drug Alcohol Depend. 2022 Sep 1;238:109564. doi: 10.1016/j.drugalcdep.2022.109564. Epub 2022 Jul 8.

    PMID: 35872529BACKGROUND

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

Study Officials

  • Phyllis Tien, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Elise Riley, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Freasier, MS, RD

CONTACT

415-683-9895heather.freasier@ucsf.edu

Nneka Emenyonu, PhD

CONTACT

Nneka.Emenyonu@ucsf.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2026

First Posted

March 10, 2026

Study Start

March 15, 2026

Primary Completion (Estimated)

March 31, 2030

Study Completion (Estimated)

March 31, 2030

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

data for MWCCS research participants are available from the JHU Institutional data repository managed by the MWCCS Data Analysis and Sharing Center (DASC) by submission of a Concept Sheet at https://statepi.jhsph.edu/mwccs/work-with-us/

Locations

US(4)