[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07461350":3,"trial-entities:NCT07461350":104,"trial-summary:NCT07461350":110},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":17,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":30,"secondary_outcomes":35,"sex":36,"minimum_age":37,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":38,"std_ages":52,"locations":55,"central_contacts":88,"overall_officials":89,"references":95,"see_also_links":103},"NCT07461350","25-44397","Stimulant and Polysubstance Use, Inflammation, and Sex Effects on Myocardial Disease in HIV","Stimulant and Polysubstance Use, Inflammation, and Sex Effects on Myocardial Disease in HIV (SPISE)","ENROLLING_BY_INVITATION","2030-03-31","2026-08","2026-08-11","2026-08-05","University of California, San Francisco","OTHER",false,"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.",null,[19],"HIV (Human Immunodeficiency Virus)",[21,22,23],"HIV","cardiac MRI","stimulant use","OBSERVATIONAL",[],{"count":27,"type":28},400,"ESTIMATED",[],[31],{"measure":32,"description":33,"timeFrame":34},"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",[],"ALL","30 Years",{"inclusion":39,"exclusion":40,"raw_text":51},[],[41,42,43,44,45,46,47,48,49,50],"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\\\u003C45 ml\u002Fmin\u002F1.73 m2;","poor venous access","pregnancy or lactation","Inclusion Criteria:\n\n\\- Participants with and without HIV enrolled in the MACS\u002FWIHS 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\\\u003C45 ml\u002Fmin\u002F1.73 m2;\n* poor venous access\n* pregnancy or lactation",[53,54],"ADULT","OLDER_ADULT",[56,64,72,80],{"facility":13,"city":57,"state":58,"zip":59,"country":60,"geoPoint":61},"San Francisco","California","94115","United States",{"lat":62,"lon":63},37.77493,-122.41942,{"facility":65,"city":66,"state":67,"zip":68,"country":60,"geoPoint":69},"Emory University, School of Medicine","Atlanta","Georgia","30322",{"lat":70,"lon":71},33.749,-84.38798,{"facility":73,"city":74,"state":75,"zip":76,"country":60,"geoPoint":77},"Johns Hopkins University","Baltimore","Maryland","21218",{"lat":78,"lon":79},39.29038,-76.61219,{"facility":81,"city":82,"state":83,"zip":84,"country":60,"geoPoint":85},"Albert Einstein College of Medicine","The Bronx","New York","10462",{"lat":86,"lon":87},40.84985,-73.86641,[],[90,93],{"name":91,"affiliation":13,"role":92},"Phyllis Tien, MD","PRINCIPAL_INVESTIGATOR",{"name":94,"affiliation":13,"role":92},"Elise Riley, PhD",[96,100],{"pmid":97,"type":98,"citation":99},"32919207","BACKGROUND","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\u002Fj.drugalcdep.2020.108252. Epub 2020 Aug 30.",{"pmid":101,"type":98,"citation":102},"35872529","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\u002Fj.drugalcdep.2022.109564. Epub 2022 Jul 8.",[],{"nct_id":4,"conditions":105,"biomarkers":109},[106,107,108],"Cardiomyopathy","HIV Infection","Substance use disorder",[],{"nct_id":4,"found":111,"summary":112,"prompt_version":122},true,{"design":113,"status":114,"heading":115,"summary":116,"follow_up":117,"word_count":118,"commitments":119,"compensation":120,"drugs_mentioned":121},"This is an observational study, meaning researchers will observe and collect information without providing any interventions. It plans to enroll 400 participants.","completed","Observational Study on Stimulant and Polysubstance Use, Inflammation, and Heart Disease in HIV","This observational research study is looking at how using stimulants and other substances affects scarring and inflammation in the heart of people with HIV. It's also exploring how sex (male or female) plays a role. The study aims to understand these connections by looking at your heart using a special scan called a cardiac MRI. You can join if you are 30 years or older and are already part of the MACS\u002FWIHS Combined Cohort Study (MWCCS) at specific sites. The study plans to include 400 participants. Success for this study means understanding the impact of substance use on heart health in people with HIV. The current recruitment status is unclear.","Not specified.",110,"You would have one study visit for a cardiac MRI, which takes up to 2 hours.","Not stated in the trial record.",[],"v2"]