Determining the Cause of Coronary Vasomotor Disorders in Patients With Ischemia and No Obstructive Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 9
- 主要终点
- The proportion of subjects with each physiologic phenotypes diagnosed with the Coroflow Cardiovascular System will be reported within 24-48 hours of the procedure.
研究概览
简要总结
The overall objective of this multi-center registry is to identify specific phenotypes of INOCA with both an anatomic evaluation (coronary angiography and intravascular imaging) and physiologic assessment with the Abbott Coroventis Coroflow Cardiovascular System, and to determine long-term outcomes.
详细描述
This is a prospective, multicenter, registry of stable patients with ischemia and no obstructive coronary artery disease (INOCA) evaluated by coronary angiography, intravascular imaging, and physiologic measurements obtained on the Coroventis Coroflow Cardiovascular System.
The Coroventis Coroflow Cardiovascular System and PressureWire™ X Guidewire (Abbott, Abbott Park, IL) are a device combination consisting of a physiology wire with wireless transmitter (Wi-Box), CoroHub Receiver, and CoroFlow Software. The PressureWire™ X guidewire is a hydrophilic-coated wire with pressure and temperature sensors that is capable of measuring physiologic indices including fractional flow reserve (FFR), resting full cycle ratio (RFR), coronary flow reserve (CFR), and the index of microcirculatory resistance (IMR). The guidewire wirelessly transmits pressure and temperature data via the Wi-Box to the CoroHub Receiver and CoroFlow Software, which is a software interface designed to display pressure measurements, thermodilution curves, and physiologic indices. This registry will enroll 500 subjects at up to 10 sites in the United States that use the Abbott Coroventis Coroflow Cardiovascular System.
The overall objective of this multi-center registry is to identify specific phenotypes of INOCA with both an anatomic evaluation (coronary angiography and intravascular imaging) and physiologic assessment with the Abbott Coroventis Coroflow Cardiovascular System, and to determine long-term outcomes. Specific goals include:
- Describe the prevalence of the following INOCA phenotypes: coronary microvascular dysfunction (CMD), vasospastic angina, mixed CMD/vasospastic angina, other disorders of coronary physiology, and non-cardiac chest pain;
- Characterize the burden of epicardial coronary artery atherosclerosis and myocardial bridging (MB) by angiography and intracoronary imaging (intravascular ultrasound or optical coherence tomography) in patients with INOCA;
- Characterize the natural history and outcomes of patients with INOCA and determine variables associated with major adverse cardiovascular events
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Suspected ischemic heart disease and is referred to undergo clinically indicated invasive coronary angiography
- •No obstructive coronary artery disease (CAD) as defined by operator visual assessment with (1) angiographically normal coronary arteries OR (2) non-obstructive CAD with angiographic stenosis < 50%, or greater than or equal to 50 but < 70% with FFR greater than or equal to 0.81 or RFR greater than or equal to 0.90
- •Willing to comply with specified follow-up evaluations. The participant or legally authorized representative has been informed of the nature of the study, agrees to its provisions, and has been provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)
排除标准
- •Pregnant or nursing
- •Any myocardial infarction at index presentation or within 90 days prior to enrollment, defined as any electrocardiogram diagnostic for myocardial infarction OR elevation in serum troponin greater than the upper limit of the site-defined reference range
- •Known left ventricular ejection fraction < 50% or cardiogenic shock requiring pressors or mechanical circulatory assistance (e.g., intra-aortic balloon pump, left ventricular assist device, other temporary cardiac support blood pump)
- •Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 (by the Modification of Diet in Renal Disease equation) or dialysis at the time of screening
- •Prior percutaneous coronary intervention
- •Planned percutaneous coronary intervention (PCI)
- •Prior coronary artery bypass graft surgery
- •Prior ST-elevation myocardial infarction
- •History of hypertrophic cardiomyopathy
- •History of infiltrative heart disease (e.g., cardiac amyloidosis)
- •New York Heart Association Class IV congestive heart failure
- •Severe mitral regurgitation
- •Severe aortic stenosis
- •Severe pulmonary hypertension (Mean pulmonary artery pressure greater than or equal to 35mmHg or echocardiographic right ventricular systolic pressure greater than or equal to 60mmHg)
- •Known history of unrepaired or repaired congenital heart disease
- •Past or pending heart transplant, or on the waiting list for organ transplant
- •Known other medical illness or known history of substance abuse that may cause non-compliance with the protocol, or is associated with a life expectancy of less than 1 year
- •Current or planned participation in a study of an investigational therapy
- •Angiographic stenosis in any major epicardial vessel ≥ 70% by visual estimate
- •Angiographic stenosis in any major epicardial vessel greater than or equal to 50% and < 70% by visual estimate with FFR less than or equal to 0.80 or RFR less than or equal to 0.89
结局指标
主要结局
The proportion of subjects with each physiologic phenotypes diagnosed with the Coroflow Cardiovascular System will be reported within 24-48 hours of the procedure.
时间窗: up to 48 hours after the procedure
The following phenotypes will be captured: Coronary microvascular dysfunction (CMD)- Criteria for a diagnosis of CMD include an abnormal Index of Microcirculatory Resistance (IMR) ≥ 25 and/or impaired Coronary Flow Reserve (CFR) ≤ 2.0; Vasospastic angina (VSA): Includes coronary vasospasm, microvascular spasm, and endothelial dysfunction. Criteria for coronary vasospasm include ≥ 90% narrowing of the epicardial vessel during acetylcholine testing and either or both angina and transient ischemic EKG changes. Microvascular spasm includes angina and/or ischemic EKG changes in the absence of spasm of the epicardial vessel during acetycholine infusion; Endothelial dysfunction as defined as angiographic diameter change less than or equal to 0% and but not greater than -89% in response to acetylcholine infusion; Mixed CMD/VSA; Any other disorders of coronary physiology.
The proportion of subjects that experience Major Adverse Cardiovascular Events (MACE)
时间窗: Up to 5 years
The proportion of subjects that experience Major Adverse Cardiovascular Events (MACE) as reported by the clinical study sites and adjudicated by the Clinical Events Committee (CEC). Reports may come from the clinical site or self report. MACE defined as a composite of cardiovascular death, myocardial infarction, hospitalization for cardiovascular causes or coronary revascularization.
The proportion of subjects that exhibit mild, moderate or severe coronary artery stenosis
时间窗: At the time of the procedure
The proportion of subjects that exhibit mild, moderate or severe coronary artery stenosis as measured by Optical Coherence Tomography (OCT), Intravascular Ultrasound (IVUS) or Quantitative Coronary Angiography (QCA). Mild stenosis is defined as less than or equal to 30%, Moderate stenosis is defined as 31%-69%, and severe stenosis is greater than or equal to 70%. The measurements will take place during the procedure and the analysis will be completed by a central core lab.
Lesion length during the procedure
时间窗: At the time of the procedure
Lesion length during the procedure will be determined for each subject by the use of OCT, IVUS or QCA and the analysis will be completed by a central core lab. Lesion length will be defined by either less than 15mm or equal to or greater than 15mm.
次要结局
- The proportion of subjects that die at any time in the study(Up to 5 years)
- The proportion of subjects that experience a Myocardial Infarction (MI) at any time during the study.(Up to 5 Years)
- The change in the quality of life (QOL) from baseline for each subject will be assessed using the QOL EQ-5D-5L questionnaire.(At baseline, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years)
- The change in depression status from baseline for each subject assessed by the Patient Health Questionnaire (PHQ)-8 questionnaire.(At baseline, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years)
- The proportion of subjects that require revascularization of their coronary arteries at any time during the study.(Up to 5 years)
- The proportion of subjects that experience Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) at any time during the study.(Up to 5 Years)
- The proportion of subjects that experience a stroke at any time during the study.(Up to 5 years)
- The change in baseline of angina symptoms for each subject. The angina status will be classified at the time of the procedure, at 30 days, 6 months, 12months and then annually up to 5 years.(At baseline, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years)
- The proportion of subjects that experience a hospitalization at any time during the study.(Up to 5 years)
- Proportion of subjects that experience major bleeding at any time during the study using the Bleeding Academic Research Consortium (BARC) bleeding type(Up to 5 years)
- Proportion of subjects that experience Major Vascular Complications at any time during the study.(Up to five 5 years)
- The proportion of subjects that require repeat coronary angiography at any time during the study.(Up to 5 years)
- The proportion of subjects with coronary lesions that experience progression to obstructive Coronary Artery Disease (CAD) at any time during the study.(Up to 5 years)
- Proportion of subjects that experience a composite of death, stroke, and MI at any time during the study.(Up to 5 years)
- Change from baseline in proportion of subjects that experience each classification of angina status during the study.(At baseline, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years)
- The proportion of subjects that experience a series of procedural outcomes as assessed by the site and adjudicated by the CEC.(Up to 48 hours after the procedure)
- The change in anxiety status from baseline for each subject. will be assessed by the Generalized Anxiety Disorder (GAD)-7 questionnaire.(At baseline, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years)