Status:
UNKNOWN
HIV Infection And Evolvement of Atherosclerotic Plaque
Lead Sponsor:
Central Clinical Hospital of the Russian Academy of Sciences
Collaborating Sponsors:
Moscow Regional Centre For HIV Care and Prevention
Conditions:
Coronary Artery Disease
Atherosclerosis, Coronary
Eligibility:
All Genders
21+ years
Brief Summary
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 sam...
Detailed Description
HIV, the virus that causes AIDS (acquired immunodeficiency syndrome), is one of the world's most serious health and development challenges. Approximately 38 million people live with HIV, and tens of m...
Eligibility Criteria
Inclusion
- all HIV-positive patients with chronic coronary syndrome or angina equivalent consistent with the manifestation of the stable coronary artery disease (in accordance with the 2019 Guidelines on Chronic Coronary Syndromes);
- patients who underwent CCTA (index procedure) with or without further PCI;
- age above 21 years old;
- patients must receive antiretroviral medications (in accordance to the 2019 HIV Russian National Guidelines; EACS Guidelines 2020);
- lesions may be either de novo or restenotic;
- patient must have one or two-vessel disease in a native coronary vessel requiring or not requiring PCI without indications for immediate bypass surgery with any SYNTAX score;
- successful uncomplicated PCI could be performed in the culprit vessels and all culprit lesions, but there should be no events or complications between the procedures of PCI in the past and 6 months prior to admission to the Chest Pain Center
- the non-culprit vessel should have no flow-limiting lesions (diameter stenosis \<39%, but any plaque burden) and must be available for imaging.The non-culprit vessel must be considered safe for imaging evaluation;
Exclusion
- any acute comorbidities;
- patient has had a documented ST-elevation acute myocardial infarction within the 24 hours prior to admission to the Chest Pain Center;
- unprotected left main lesion location;
- culprit lesion is located within or distal to an arterial or saphenous vein graft;
- untreated significant coronary lesion with a \>50-75% diameter stenosis remaining in the culprit vessel after the planned intervention (branch stenosis is permitted);
- lesion or vessel contains visible thrombus within the imaging procedure;
- patient has an additional lesion that requires intervention within 180 days after the initial hospitalization;
- any diameter stenosis more than 75% in the non-culprit vessel;
- indications for immediate bypass surgery within one year of enrollment with the SYNTAX above 34 (multi-vessel disease requiring intervention in all three major coronary arteries);
- creatinine \>150 mmol/L;
- need for dialysis;
- severe endocrine disorders (diabetes is permitted) including pre-existing thyroid diseases;
- decompensated hypotension or heart failure requiring intubation, inotropes,intravenous diuretics, or intra-aortic balloon counterpulsation;
- patient has a known hypersensitivity, allergy, or contraindication to any of the following: aspirin, heparin, clopidogrel, and ticlopidine, or to contrast that cannot be adequately pre-medicated;
- presence of cardiac implants;
- presence of cardiogenic shock;
- patient has a known left ventricular ejection fraction \<39%;
- refractory ventricular arrhythmia;
- acute conduction system disease requiring a pacemaker;
- patient has had a recent PCI (last 6 months prior to admission to the Chest Pain Center) unless the patient is undergoing a staged procedure for dual vessel treatment
- prior participation in this study or patient is currently enrolled in another investigational use device, imaging, or drug study that has not been reached its primary endpoint;
- mental diseases, inability for cooperation;
- pregnancy;
- stroke or CVA;
- gastrointestinal bleeding.
Key Trial Info
Start Date :
January 5 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 5 2023
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04810364
Start Date
January 5 2020
End Date
December 5 2023
Last Update
March 29 2022
Active Locations (2)
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1
Central Clinical Hospital of the Russian Academy of Sciences
Moscow, Russia, 117593
2
Moscow Regional Centre For HIV Care and Prevention
Moscow, Russia, 129110