Last reviewed · How we verify

NCT04810364: HIVE

HIV Infection And Evolvement of Atherosclerotic Plaque

Status unknown Last updated 29 March 2022
What this trial tests

trial testing Quantitative coronary angiography, intravascular imaging with percutaneous intervention in Coronary Artery Disease in 1,000 participants. Status unknown.

Timeline
5 January 2020
Primary endpoint
5 December 2022
5 December 2023

Quick facts

Lead sponsorCentral Clinical Hospital of the Russian Academy of Sciences
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment1,000
Start date5 January 2020
Primary completion5 December 2022
Estimated completion5 December 2023
Sites2 locations across Russia

Drugs / interventions tested

Conditions studied

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:

Other recruiting trials for Coronary Artery Disease

Currently open trials in the same condition.

Verify against primary sources

Data sources for this page

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