Stimulant and Polysubstance Use, Inflammation, and Sex Effects on Myocardial Disease in HIV (SPISE)

March 4, 2026 updated by: University of California, San Francisco

Stimulant and Polysubstance Use, Inflammation, and Sex Effects on Myocardial Disease in HIV (SPISE)

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • University of California, San Francisco
        • Contact:
        • Principal Investigator:
          • Phyllis Tien, MD
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University, School of Medicine
        • Contact:
        • Principal Investigator:
          • Cecile Lahiri, MD
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Johns Hopkins University
        • Principal Investigator:
          • Katherine Wu, MD
        • Contact:
        • Principal Investigator:
          • Todd Brown, MD
    • New York
      • The Bronx, New York, United States, 10462
        • Albert Einstein College of Medicine
        • Contact:
        • Principal Investigator:
          • David Hannah, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac MRI
Time Frame: Visit 1, up to 2 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Phyllis Tien, MD, University of California, San Francisco
  • Principal Investigator: Elise Riley, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2026

Primary Completion (Estimated)

March 31, 2030

Study Completion (Estimated)

March 31, 2030

Study Registration Dates

First Submitted

February 20, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-44397
  • 1RM1DA063351 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV (Human Immunodeficiency Virus)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe