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NCT04810364: HIVE
HIV Infection And Evolvement of Atherosclerotic Plaque
trial testing Quantitative coronary angiography, intravascular imaging with percutaneous intervention in Coronary Artery Disease in 1,000 participants. Status unknown.
5 December 2022
Quick facts
| Lead sponsor | Central Clinical Hospital of the Russian Academy of Sciences |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 1,000 |
| Start date | 5 January 2020 |
| Primary completion | 5 December 2022 |
| Estimated completion | 5 December 2023 |
| Sites | 2 locations across Russia |
Drugs / interventions tested
- Quantitative coronary angiography, intravascular imaging with percutaneous intervention
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
- Atherosclerosis, Coronary — all drugs for Atherosclerosis, Coronary →
- Hiv — all drugs for Hiv →
- HIV Infections — all drugs for HIV Infections →
Sponsor
Central Clinical Hospital of the Russian Academy of Sciences
Who can join
21 and older, any sex, with Coronary Artery Disease or Atherosclerosis, Coronary. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In a prospective multi-center observational study, 200 HIV-infected patients treated with antiretroviral treatment (ART) and who suffered from coronary artery disease (CAD) will be enrolled. Blood samples for biological parameters will be collected with all participants: lipid profile and markers of systemic inflammation specific for HIV-infection (lipopolysaccharide-binding protein; cytokines: IL-1β, IL-6, IL-8, IL-10, TNF -α, INF-γ, INF-α; procalcitonin; inflammatory hsCRP). All of them will undergo functional testing (Echo, CMR both at rest and stress if necessary) and invasive imaging with QCA, FFR, QFR, OCT, IVUS, VH-IVUS, NIRS. Patients will be treated according to the current and previous recommendations. Both medical treatment and percutaneous transluminal coronary angioplasty (PTCA) with or without stenting will be done. Collected data will be analyzed: correlation between ART, blood test results, coronary angiography results, including performed PTCA, history of myocardial infarctions, and other cardiovascular events. The follow-up period will achieve 12 months prospectively with collected clinical events and imaging outcomes which will be determined at the baseline and 12-month follow-up. The independent ethics expertise will be provided by the Central Clinical Hospital of the Russian Academy of Sciences (Moscow, Russia). The monitoring of the clinical data with imaging will be provided by The Ethics Board of Central Clinical Hospital of the Russian Academy of Sciences.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04810364
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04810364 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Central Clinical Hospital of the Russian Academy of Sciences
- Last refreshed: 29 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04810364.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing