Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 7:47 PM
Study NCT ID:
NCT07461350
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stimulant and Polysubstance Use, Inflammation, and Sex Effects on Myocardial Disease in HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2030-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-02-20', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac MRI', 'timeFrame': 'Visit 1, up to 2 hours', 'description': 'CMR assessments to provide detailed myocardial characterization (e.g. diffuse inflammation (nT1), myocardial fibrosis (ECV), and myocardial scar assessed using LGE)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV', 'cardiac MRI', 'stimulant use'], 'conditions': ['HIV (Human Immunodeficiency Virus)']}, 'referencesModule': {'references': [{'pmid': '32919207', 'type': 'BACKGROUND', 'citation': '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': '35872529', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with and without HIV enrolled in the MACS/WIHS Combined Cohort Study (MWCCS) Atlanta, Baltimore, Bronx, and San Francisco study sites', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Participants with and without HIV enrolled in the MACS/WIHS Combined Cohort Study (MWCCS) Atlanta, Baltimore, Bronx, and San Francisco study sites\n\nExclusion Criteria:\n\n* Standard contraindications to MRI\n* claustrophobia,\n* metal implants,\n* large body size (weight \\>350 lbs or abdominal sagittal diameter \\>70 cm),\n* pregnancy)\n* Gadolinium risk\n* severe or uncontrolled asthma,\n* visit day eGFR\\<45 ml/min/1.73 m2;\n* poor venous access\n* pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT07461350', 'acronym': 'SPISE', 'briefTitle': 'Stimulant and Polysubstance Use, Inflammation, and Sex Effects on Myocardial Disease in HIV', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Stimulant and Polysubstance Use, Inflammation, and Sex Effects on Myocardial Disease in HIV (SPISE)', 'orgStudyIdInfo': {'id': '25-44397'}, 'secondaryIdInfos': [{'id': '1RM1DA063351', 'link': 'https://reporter.nih.gov/quickSearch/1RM1DA063351', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Current Stimulant Use', 'description': 'Used stimulants (amphetamines, cocaine, etc.) in past year'}, {'label': 'Past Stimulant Use', 'description': 'Previously used stimulants (amphetamines, cocaine, etc.) but not in the last 12 months'}, {'label': 'No Stimulant use', 'description': 'Never used stimulants (amphetamines, cocaine, etc.)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Heather Freasier, MS, RD', 'role': 'CONTACT', 'email': 'heather.freasier@ucsf.edu', 'phone': '415-683-9895'}, {'name': 'Phyllis Tien, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'contacts': [{'name': 'Rachael Farah-Abraham, PhD, MSc, CPH', 'role': 'CONTACT', 'email': 'rachael.farah-abraham@emory.edu', 'phone': '404-251-8940'}, {'name': 'Cecile Lahiri, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Emory University, School of Medicine', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '21218', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'contacts': [{'name': 'Jacquett Batson, MS, ITS', 'role': 'CONTACT', 'email': 'jjohns20@jhu.edu', 'phone': '410-955-4912'}, {'name': 'Todd Brown, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Katherine Wu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '10462', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'contacts': [{'name': 'Janet Brown-Friday, RN, MSN, MPH', 'role': 'CONTACT', 'email': 'janet.brown@einsteinmed.edu', 'phone': '718-654-7099', 'phoneExt': '2857'}, {'name': 'David Hannah, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Albert Einstein College of Medicine', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'centralContacts': [{'name': 'Heather Freasier, MS, RD', 'role': 'CONTACT', 'email': 'heather.freasier@ucsf.edu', 'phone': '415-683-9895'}, {'name': 'Nneka Emenyonu, PhD', 'role': 'CONTACT', 'email': 'Nneka.Emenyonu@ucsf.edu'}], 'overallOfficials': [{'name': 'Phyllis Tien, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Elise Riley, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}