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NCT Number: NCT07461350

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

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.

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Key information

Conditions

HIV (Human Immunodeficiency Virus) Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Francisco, San Francisco, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Heather Freasier, MS, RD

CONTACT

[email protected]

415-683-9895

Nneka Emenyonu, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: SPISE

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Mar 10, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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