Coronary Artery DiseaseHIVENCT04810364
HIV Infection And Evolvement of Atherosclerotic Plaque
An observational study of Coronary Artery Disease and Atherosclerosis, Coronary, run by Central Clinical Hospital of the Russian Academy of Sciences at 2 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Coronary Artery Disease, Atherosclerosis, Coronary, Hiv
- What is being tested?
- Quantitative coronary angiography, intravascular imaging with percutaneous intervention
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 2 sitesRussia
- Study dates
- 5 Jan 2020to 5 Dec 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All stable chest pain comers with a chronic coronary syndrome without acute angina who underwent QCA, applicable intravascular imaging (OCT, IVUS, VH-IVUS, NIRS) with or without further PCI.
Who may be able to join
- 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;
Who cannot join
- 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;
Show all 25Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Central Clinical Hospital of the Russian Academy of Sciences
Moscow, 117593
Moscow Regional Centre For HIV Care and Prevention
Moscow, 129110
About this study
Official title: Systemic Inflammation and Progression of Atherosclerosis in HIV Patients Underwent Noninvasive and Invasive Multimodality Imaging
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.
Read more
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.
Read the 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 millions of people have died of AIDS-related causes since the beginning of the epidemic.
However, with increasing access to effective HIV prevention, diagnosis, treatment, and care, including opportunistic infections, HIV infection has transformed from an irreversible terminal illness to chronic disease. Unfortunately, increased life expectancy has increased the risk of other chronic diseases such as cardiovascular diseases (CVD). Actually, CVD has become the most common cause of death in HIV-infected individuals. The risk of myocardial infarction and coronary atherosclerosis prevalence is nearly twice as high in people living with HIV than in the general population. Statins are effective primary prevention for CAD events; however, there are no specific statin use guidelines in HIV. Besides, there is not enough information about systemic inflammation markers and their correlation with atherosclerosis severity.
Nowadays, using invasive imaging, including quantitative coronary angiography with or without further percutaneous coronary intervention, optical coherence tomography/ OCT, intravascular ultrasound/ IVUS, VH-IVUS, near-infrared spectroscopy/ NIRS, cardiovascular events can be predicted and prevented.
In a prospective multicenter 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 (Quantitative Coronary Angiography), FFR (Fractional Flow Reserve), QFR (Quantitative Flow Reserve), OCT (Optical Coherence Tomography), IVUS (Intravascular Ultrasound), VH-IVUS (Virtual Histology - IVUS), NIRS (Near Infrared Spectroscopy).
Patients will be treated according to the current and previous recommendations: The 2019 HIV Russian National Guidelines; EACS Guidelines 2020; The AHA scientific statement Characteristics, Prevention, and Management of Cardiovascular Disease in People Living With HIV A Scientific Statement From the American Heart Association. Circulation 2019; ESC/EACTS Guidelines on Myocardial Revascularization 2018; 2019 Guidelines on Chronic Coronary Syndromes.
Both medical treatment and percutaneous transluminal coronary angioplasty (PTCA) with or without stenting will be provided.
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.
The clinical data of the HIVE trial include information of the complex examination with:
- invasive imaging with QCA, FFR, QFR, OCT, IVUS, VH-IVUS, NIRS,
- two interviews with the risk factor modification recommendations,
- blood tests:
- lipid profile (total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol, VLDL cholesterol),
- 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),
- biochemical blood test (glucose, asparagine transaminase, alanine transaminase, total bilirubin, creatinine, markers of the myocardium damage (myoglobin, troponin I, creatine kinase, creatine kinase-MB, brain natriuretic peptide - NT-proBNP),
- complete blood count,
- ECG,
- Echo,
- CMR results
The prospective patients will be tested with HeartAge, SCORE, Duke ACC/ AHA, Duke - DCS, Diamond-Forrester - DFM, The Seattle Angina Questionnaire - SAQ, DukeActivity Status Index -DASI, and EQ-5D-5L, scores that are specific for HIV: EuroSida AIDS/Death risk score, FENCE score, CSRFENCE Score. Patients will be screened for the major risk factors and their modification: unhealthy blood cholesterol levels, high blood pressure, smoking, insulin resistance, diabetes, overweight or obesity, lack of physical activity, unhealthy diet, older age, genetic or lifestyle factors, family history of early heart diseases.
The PCI and PTCA will be undergone by the 2020 ESC/EACTS Guidelines on Myocardial Revascularization. The imaging data from non-invasive (CMR, Echo) and invasive (QCA, FFR, QFR, OCT, IVUS, VH-IVUS, NIRS) methods will be handled and analyzed with the expert-level post-processing imaging software (Medis Suite Solutions: MR, XA, QFR, CT, Intravascular, Ultrasound) from Medis Medical Imaging Systems B.V. (Leiden, The Netherlands).
Our study aims to evaluate the severity of coronary atherosclerosis in HIV-patients with CAD and its correlation with markers of systemic inflammation specific for HIV-infection (LBP; cytokines: IL-1β, IL-6, IL-8, IL-10, TNF -α, INF-γ, INF-α; procalcitonin; inflammatory hsCRP) and to estimate their value in preventing cardiovascular events.
- Conditions
- Coronary Artery Disease, Atherosclerosis, Coronary, Hiv, HIV Infections, Stable Chronic Angina
- Being tested
- Quantitative coronary angiography, intravascular imaging with percutaneous intervention
- Keywords
- Coronary Angiography, Echocardiography, Markers of Inflammation, Lipid Profile, Percutaneous transluminal coronary angioplasty, Percutaneous coronary intervention, Coronary Artery Diseases, Atherosclerosis, HIV, Plaque burden, SYNTAX score, Fractional flow reserve, Optical coherence tomography, Intravascular ultrasound, Intravascular imaging
- Medical subject headings
- Coronary Artery Disease, Acquired Immunodeficiency Syndrome, HIV Infections, Angina, Stable, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative coronary angiography, intravascular imaging with percutaneous interventionRadiation
Also called QCA, Coronary intravascular imaging
Coronaries will be shot with AXIOM Artis dFC (Siemens, Munich,Germany) or systems from any other vendors. In case if necessary the procedure will be delayed for intravascular imaging (OCT, IVUS, VH-IVUS, NIRS) and/ or percutaneous intervention (with implantation of the medical device).
| Study group | Role | What they receive |
|---|---|---|
| All HIV-positive patients with chronic coronary syndrome | The Group includes all HIV-positive patients with stable chest pain. The progression of atherosclerosis will be quantitatively characterized by the parameters of the lesions (e.g. plaque burden, cap thickness, arterial remodeling, presence of erosions or rupture, malaposition of the stent, a vessel injury score, etc.). The imaging data will be handled with expert-level post-processing software. Receives: Radiation: Quantitative coronary angiography, intravascular imaging with percutaneous intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of per cent of plaque burden from baseline to follow-up as assessed by QCA
Plaque burden for both culprit and non-culprit lesions will be calculated as a lesion volume (vessel volume-lumen volume)/lumen volume x 1 00. The progression of atherosclerosis and plaque composition in patients receiving different antiretroviral medications will be quantitatively characterized by the parameters of the lesions. The imaging data will be handled with the expert-level post-processing software.
Measured: At 12 months after the baseline imaging procedure
Number of participants with major adverse cardiac events that are related to plaque burden
The composite of cardiac death, cardiac arrest, myocardial infarction, acute coronary syndrome, revascularization by coronary artery bypass surgery (CABG) or percutaneous coronary intervention (PCI), or rehospitalization for angina for patients with both culprit- and non-culprit-lesion-related events. Event rates will be determined at: hospital, at 12months.
Measured: At 12 months after the baseline imaging procedure
Diagnostic value of systemic inflammation markers for risk stratification
To determine prognostic value of systemic inflammation markers (LBP, Lipopolysaccharide binding protein, μg/mL; cytokines: IL-1β, pg/mL; IL-6, pg/mL; IL-8, pg/mL; IL-10, pg/mL; TNF-α, pg/mL; INF-γ, pg/mL; INF-α, pg/mL; procalcitonin, pg/L; inflammatory hsCRP, mg/L) to predict cardiovascular events in patients with HIV.
Measured: At 12 months after the blood testing and the baseline imaging procedure
Invasive assessment of fractional flow reserve for risk stratification
To determine the prognostic value of FFR (fractional flow reserve) when below 0.75-0.80 in comparison with the relevant invasive results of QCA (quantitative coronary angiography), QFR (quantitative flow reserve), OCT (optical coherence tomography), IVUS (intravascular ultrasound), VH-IVUS (virtual histology IVUS), NIRS (near-infrared spectroscopy) handled with the expert-level postprocessing software for predicting cardiac death and nonfatal myocardial infarction.
Measured: At 12 months after the baseline imaging procedure
Secondary outcomes (9)
Change of serologic marker of inflammation CRP from baseline to follow-up
To evaluate a role of HIV and invasive intervention on the inflammatory marker CRP (C-reactive protein, mg/L) as well as its predictive role in comparison with the relevant biochemical variables (LBP, Lipopolysaccharide binding protein, μg/mL; cytokines: IL-1β, pg/mL; IL-6, pg/mL; IL-8, pg/mL; IL-10, pg/mL; TNF-α, pg/mL; INF-γ, pg/mL; INF-α, pg/mL; procalcitonin, pg/L).
Measured: At 12 months after the baseline imaging procedure
Number of participants with procedural success
This is the cumulative variable comprising outcomes of each procedure. Ability to complete the imaging procedures without imaging device or procedure related complication
Measured: At 12 months after the baseline imaging procedure
Change of complexity of coronary artery disease from baseline to follow-up as assessed by SYNTAX score I
Calculated with the version 2.11 of the SYNTAX (Synergy between percutaneous coronary intervention with taxus and cardiac surgery) Score I calculator at: hospital, at 12 months. The variable will be adjusted for CCTA and QCA due to technical limitations. CT SYNTAX score I will be calculated within recommendations Papadopoulou SL, et al, 2013 (JACC Cardiovasc Imaging. 2013 Mar;6(3):413-5. doi: 10.1016/j.jcmg.201 2.09.01 3; http://www.syntaxscore.com/calculator/syntaxscore/frameset.htm; https://syntaxscore2020.com/).
Measured: At 12 months after the baseline imaging procedure
Change of complexity of coronary artery disease from baseline to follow-up as assessed by SYNTAX score II
Calculated with the version 2.11 of the SYNTAX (Synergy between percutaneous coronary intervention with taxus and cardiac surgery) Score II calculator at: hospital, at 12 months. The variable will be adjusted for CCTA and QCA due to technical limitations. CT SYNTAX score II will be calculated within recommendations Papadopoulou SL, et al, 2013 (JACC Cardiovasc Imaging. 2013 Mar;6(3):413-5. doi: 10.1016/ j.jcmg.201 2.09.01 3; http://www.syntaxscore.com/calculator/syntaxscore/framesetss2.htm; https://syntaxscore2020.com/).
Measured: At 12 months after the baseline imaging procedure
Change of fractional flow reserve (FFR) from baseline to follow-up that are related to the progress of atherosclerosis
FFR less than 0.75 considered as hemodynamically significant and estimated for all the lesions. FFR will be compared with other variables to evaluate any correlations.
Measured: At 12 months after the baseline imaging procedure
Change of complexity of coronary artery disease from baseline to follow-up as assessed by Leaman Coronary Score
Calculated within the recommendations of Leaman DM, et al, 1981 (Circulation 63, No. 2, 1981) at: hospital, at 12months. The variable will be adjusted for CTA and 3D QCA due to technical limitations. CT-Leaman score will be calculated within the recommendations of Mushtaq S, et al, 2015 (CircCardiovasc Imaging. 2015 Feb;8(2):e002332.doi: 1 0.11 61 /CIRCIMAGING.11 4.002332).
Measured: At 12 months after the baseline imaging procedure
Number of participants with encephalopathy
The clinical manifestation (medical history, mental status testing with the mini-mental state examination (MMSE) and mini-cog, a physical and neurological exam) of degenerative and/ or paroxysmal encephalopathy will be evaluated with multi-slice computed tomography (MSCT)-screening of the cerebrovascular disease and Alzheimer's disease in association with markers of Herpes Simplex Virus Type 1 (HSV-1 ) and fungi.
Measured: At 12 months after the baseline imaging procedure
Number of chest pain patients with non-obstructive coronary artery disease
Patients with the negative acute markers of the myocardial damage (myoglobin, troponin I, CK, CK-MB, NT-proBNP) and without hemodynamically significant (<50 percent stenosis) coronary atherosclerosis verified by QCA
Measured: At 12 months after the baseline imaging procedure
Number of chest pain patients without coronary artery disease
Patients with the negative acute markers of the myocardial damage (myoglobin, troponin I, CK, CK-MB, NT-proBNP) and without coronary atherosclerosis verified by MSCT
Measured: At 12 months after the baseline imaging procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start5 Jan 2020
- Primary completion5 Dec 2022 (estimated)
- Study completion5 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Central Clinical Hospital of the Russian Academy of Sciences
- Sponsor type
- Other government
- Collaborators
- Moscow Regional Centre For HIV Care and Prevention
- Responsible party
- Sponsor
- Investigators
- Diana Izimarieva, MD, Principal investigator, Central Clinical Hospital of the Russian Academy of SciencesElena Orlova-Morozova, MD, PhD, Study director, Moscow Regional Centre For HIV Care and PreventionAlexey Sozykin, MD, D.Sc, Study chair, Central Clinical Hospital of the Russian Academy of SciencesAlexey Nikitin, M.D., D.Sc., Ph.D., Principal investigator, Central Clinical Hospital of the Russian Academy of SciencesEugene Averin, M.D., D.Sc., Ph.D., Principal investigator, Central Clinical Hospital of the Russian Academy of SciencesAlexey Shevchenko, M.D., D.Sc., Ph.D., Study director, Pirogov Russian National Research Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810364
- Sponsor's protocol ID
- HIVE
- Acronym
- HIVE
- Status last verified
- Mar 2022
- First submitted
- 12 Mar 2021
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The specific design of the study makes it infeasible to share the required information with the other researchers. Notwithstanding in case of the scientific inquiries regarding meta-analysis the situation might be considered.
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Inflammation and Progression of Atherosclerosis in HIV Patients Underwent Noninvasive and Invasive Multimodality Imaging
- ClinicalTrials.gov ID
- NCT04810364
- Acronym / sponsor ID
- HIVE / HIVE
- Conditions
- Coronary Artery Disease, Atherosclerosis, Coronary, Hiv, HIV Infections, Stable Chronic Angina
- Keywords
- Coronary Angiography, Echocardiography, Markers of Inflammation, Lipid Profile, Percutaneous transluminal coronary angioplasty, Percutaneous coronary intervention, Coronary Artery Diseases, Atherosclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Central Clinical Hospital of the Russian Academy of SciencesOther government
- Collaborators
- Moscow Regional Centre For HIV Care and Prevention
- Study start
- 5 Jan 2020 (actual)
- Primary completion
- 5 Dec 2022 (estimated)
- Study completion
- 5 Dec 2023 (estimated)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 millions of people have died of AIDS-related causes since the beginning of the epidemic.
However, with increasing access to effective HIV prevention, diagnosis, treatment, and care, including opportunistic infections, HIV infection has transformed from an irreversible terminal illness to chronic disease. Unfortunately, increased life expectancy has increased the risk of other chronic diseases such as cardiovascular diseases (CVD). Actually, CVD has become the most common cause of death in HIV-infected individuals. The risk of myocardial infarction and coronary atherosclerosis prevalence is nearly twice as high in people living with HIV than in the general population. Statins are effective primary prevention for CAD events; however, there are no specific statin use guidelines in HIV. Besides, there is not enough information about systemic inflammation markers and their correlation with atherosclerosis severity.
Nowadays, using invasive imaging, including quantitative coronary angiography with or without further percutaneous coronary intervention, optical coherence tomography/ OCT, intravascular ultrasound/ IVUS, VH-IVUS, near-infrared spectroscopy/ NIRS, cardiovascular events can be predicted and prevented.
In a prospective multicenter 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 (Quantitative Coronary Angiography), FFR (Fractional Flow Reserve), QFR (Quantitative Flow Reserve), OCT (Optical Coherence Tomography), IVUS (Intravascular Ultrasound), VH-IVUS (Virtual Histology - IVUS), NIRS (Near Infrared Spectroscopy).
Patients will be treated according to the current and previous recommendations: The 2019 HIV Russian National Guidelines; EACS Guidelines 2020; The AHA scientific statement Characteristics, Prevention, and Management of Cardiovascular Disease in People Living With HIV A Scientific Statement From the American Heart Association. Circulation 2019; ESC/EACTS Guidelines on Myocardial Revascularization 2018; 2019 Guidelines on Chronic Coronary Syndromes.
Both medical treatment and percutaneous transluminal coronary angioplasty (PTCA) with or without stenting will be provided.
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.
The clinical data of the HIVE trial include information of the complex examination with:
- invasive imaging with QCA, FFR, QFR, OCT, IVUS, VH-IVUS, NIRS,
- two interviews with the risk factor modification recommendations,
- blood tests:
- lipid profile (total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol, VLDL cholesterol),
- 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),
- biochemical blood test (glucose, asparagine transaminase, alanine transaminase, total bilirubin, creatinine, markers of the myocardium damage (myoglobin, troponin I, creatine kinase, creatine kinase-MB, brain natriuretic peptide - NT-proBNP),
- complete blood count,
- ECG,
- Echo,
- CMR results
The prospective patients will be tested with HeartAge, SCORE, Duke ACC/ AHA, Duke - DCS, Diamond-Forrester - DFM, The Seattle Angina Questionnaire - SAQ, DukeActivity Status Index -DASI, and EQ-5D-5L, scores that are specific for HIV: EuroSida AIDS/Death risk score, FENCE score, CSRFENCE Score. Patients will be screened for the major risk factors and their modification: unhealthy blood cholesterol levels, high blood pressure, smoking, insulin resistance, diabetes, overweight or obesity, lack of physical activity, unhealthy diet, older age, genetic or lifestyle factors, family history of early heart diseases.
The PCI and PTCA will be undergone by the 2020 ESC/EACTS Guidelines on Myocardial Revascularization. The imaging data from non-invasive (CMR, Echo) and invasive (QCA, FFR, QFR, OCT, IVUS, VH-IVUS, NIRS) methods will be handled and analyzed with the expert-level post-processing imaging software (Medis Suite Solutions: MR, XA, QFR, CT, Intravascular, Ultrasound) from Medis Medical Imaging Systems B.V. (Leiden, The Netherlands).
Our study aims to evaluate the severity of coronary atherosclerosis in HIV-patients with CAD and its correlation with markers of systemic inflammation specific for HIV-infection (LBP; cytokines: IL-1β, IL-6, IL-8, IL-10, TNF -α, INF-γ, INF-α; procalcitonin; inflammatory hsCRP) and to estimate their value in preventing cardiovascular events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All HIV-positive patients with chronic coronary syndrome | – | Radiation: Quantitative coronary angiography, intravascular imaging with percutaneous interventionThe Group includes all HIV-positive patients with stable chest pain. The progression of atherosclerosis will be quantitatively characterized by the parameters of the lesions (e.g. plaque burden, cap thickness, arterial remodeling, presence of erosions or rupture, malaposition of the stent, a vessel injury score, etc.). The imaging data will be handled with expert-level post-processing software. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All stable chest pain comers with a chronic coronary syndrome without acute angina who underwent QCA, applicable intravascular imaging (OCT, IVUS, VH-IVUS, NIRS) with or without further PCI.
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (25 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative coronary angiography, intravascular imaging with percutaneous interventionAlso: QCA, Coronary intravascular imagingCoronaries will be shot with AXIOM Artis dFC (Siemens, Munich,Germany) or systems from any other vendors. In case if necessary the procedure will be delayed for intravascular imaging (OCT, IVUS, VH-IVUS, NIRS) and/ or percutaneous intervention (with implantation of the medical device). | Radiation | All HIV-positive patients with chronic coronary syndrome |
Primary outcome
Change of per cent of plaque burden from baseline to follow-up as assessed by QCA
Time frame: At 12 months after the baseline imaging procedure
Plaque burden for both culprit and non-culprit lesions will be calculated as a lesion volume (vessel volume-lumen volume)/lumen volume x 1 00. The progression of atherosclerosis and plaque composition in patients receiving different antiretroviral medications will be quantitatively characterized by the parameters of the lesions. The imaging data will be handled with the expert-level post-processing software.
Number of participants with major adverse cardiac events that are related to plaque burden
Time frame: At 12 months after the baseline imaging procedure
The composite of cardiac death, cardiac arrest, myocardial infarction, acute coronary syndrome, revascularization by coronary artery bypass surgery (CABG) or percutaneous coronary intervention (PCI), or rehospitalization for angina for patients with both culprit- and non-culprit-lesion-related events. Event rates will be determined at: hospital, at 12months.
Diagnostic value of systemic inflammation markers for risk stratification
Time frame: At 12 months after the blood testing and the baseline imaging procedure
To determine prognostic value of systemic inflammation markers (LBP, Lipopolysaccharide binding protein, μg/mL; cytokines: IL-1β, pg/mL; IL-6, pg/mL; IL-8, pg/mL; IL-10, pg/mL; TNF-α, pg/mL; INF-γ, pg/mL; INF-α, pg/mL; procalcitonin, pg/L; inflammatory hsCRP, mg/L) to predict cardiovascular events in patients with HIV.
Invasive assessment of fractional flow reserve for risk stratification
Time frame: At 12 months after the baseline imaging procedure
To determine the prognostic value of FFR (fractional flow reserve) when below 0.75-0.80 in comparison with the relevant invasive results of QCA (quantitative coronary angiography), QFR (quantitative flow reserve), OCT (optical coherence tomography), IVUS (intravascular ultrasound), VH-IVUS (virtual histology IVUS), NIRS (near-infrared spectroscopy) handled with the expert-level postprocessing software for predicting cardiac death and nonfatal myocardial infarction.
9 secondary outcomes
Change of serologic marker of inflammation CRP from baseline to follow-up
Time frame: At 12 months after the baseline imaging procedure
Number of participants with procedural success
Time frame: At 12 months after the baseline imaging procedure
Change of complexity of coronary artery disease from baseline to follow-up as assessed by SYNTAX score I
Time frame: At 12 months after the baseline imaging procedure
Change of complexity of coronary artery disease from baseline to follow-up as assessed by SYNTAX score II
Time frame: At 12 months after the baseline imaging procedure
Change of fractional flow reserve (FFR) from baseline to follow-up that are related to the progress of atherosclerosis
Time frame: At 12 months after the baseline imaging procedure
Change of complexity of coronary artery disease from baseline to follow-up as assessed by Leaman Coronary Score
Time frame: At 12 months after the baseline imaging procedure
Number of participants with encephalopathy
Time frame: At 12 months after the baseline imaging procedure
Number of chest pain patients with non-obstructive coronary artery disease
Time frame: At 12 months after the baseline imaging procedure
Number of chest pain patients without coronary artery disease
Time frame: At 12 months after the baseline imaging procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Central Clinical Hospital of The Russian Academy of SciencesLink provided by the sponsor.
- Moscow Regional Centre of HIV Care and PreventionLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The specific design of the study makes it infeasible to share the required information with the other researchers. Notwithstanding in case of the scientific inquiries regarding meta-analysis the situation might be considered.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Izimarieva, MD principal investigator
Central Clinical Hospital of the Russian Academy of Sciences
Elena Orlova-Morozova, MD, PhD study director
Moscow Regional Centre For HIV Care and Prevention
Alexey Sozykin, MD, D.Sc study chair
Central Clinical Hospital of the Russian Academy of Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Atherosclerosis, Coronary, run by Central Clinical Hospital of the Russian Academy of Sciences at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of per cent of plaque burden from baseline to follow-up as assessed by QCA (time frame: At 12 months after the baseline imaging procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.