Menu
Not yet recruiting NCT07461350

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

Observational HIV (Human Immunodeficiency Virus)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: HIV (Human Immunodeficiency Virus). Basic parameters: from 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Cardiac MRI [Time frame: Visit 1, up to 2 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 4 centers
  • University of California, San Francisco — San Francisco
  • Emory University, School of Medicine — Atlanta
  • Johns Hopkins University — Baltimore
  • Albert Einstein College of Medicine — The Bronx

Publications

  • 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 32919207
  • 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 35872529

Identifiers

NCT: NCT07461350 · 25-44397 · 1RM1DA063351

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗