Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04810364
Status:
UNKNOWN
Last Update Posted:
2022-03-29
First Post:
2021-03-12
Brief Title:
HIV Infection And Evolvement of Atherosclerotic Plaque
Sponsor:
Central Clinical Hospital of the Russian Academy of Sciences
Organization:
Central Clinical Hospital of the Russian Academy of Sciences
Study Overview
Official Title:
Systemic Inflammation and Progression of Atherosclerosis in HIV Patients Underwent Noninvasive and Invasive Multimodality Imaging
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HIVE
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 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
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 worlds 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 ESCEACTS 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
1 invasive imaging with QCA FFR QFR OCT IVUS VH-IVUS NIRS
2 two interviews with the risk factor modification recommendations
3 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
4 ECG
5 Echo
6 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 AIDSDeath 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 ESCEACTS 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 BV 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
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 ESCEACTS 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
1 invasive imaging with QCA FFR QFR OCT IVUS VH-IVUS NIRS
2 two interviews with the risk factor modification recommendations
3 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
4 ECG
5 Echo
6 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 AIDSDeath 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 ESCEACTS 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 BV 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None