Multicenter Registry of Coronary Flow-Derived Indexes for Coronary Microvascular Disease (Multicenter FLOW-CMD Registry)
- Conditions
- Coronary Artery DiseaseCoronary Microvascular DiseaseIschemic Heart Disease
- Interventions
- Diagnostic Test: Invasive physiologic assessmentDiagnostic Test: Intravascular imaging
- Registration Number
- NCT05369182
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Multicenter FLOW-CMD registry is a prospective, multi-center, registry study.
The aim of the study is to evaluate prognostic implications of coronary microvascular disease (CMD) in patients with ischemic heart disease (IHD) undergoing revascularization decision using FFR or other non-hyperemic pressure ratios.
- Detailed Description
The diagnostic and therapeutic strategies in patients with coronary artery disease (CAD) have focused on identifying and alleviating both extent and severity of myocardial ischemia, as it is the most important prognostic fator. Thus, fractional flow reserve (FFR) has been a standard method for identifying ischemia-related epicardial coronary stenosis, accruing an abundance of clinical evidence on the benefit of FFR-guided treatment decisions. However, a high FFR value (\>0.80) does not necessarily imply freedom from future events. Indeed, clinical events still occur in patients who are deferred based on high FFR. The microvasculature is one of the main components of coronary circulatory system, and the presence of microvascular disease may contribute to clinical events in patients without epicardial coronary stenosis. In the cardiac catheterization laboratory, microvascular disease can be assessed using a pressure/temperature-sensor coronary wire or a Doppler wire. Previous studies have demonstrated the incremental prognostic implications of coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) in patients with high FFR, and the recent European guidelines supported the importance of invasive physiologic assessment using CFR and IMR in patients with stable coronary artery disease. Furthermore, recent Expert Consensus Documents and the European Society of Cardiology guideline of Chronic Coronary Syndrome have underlined the importance of evaluating coronary microvascular disease (CMD) in patients with ischemic heart disease (IHD) and proposed an universal definition of CMD based on: 1) functionally non-obstructive CAD defined by a fractional flow reserve (FFR)\>0.80 and 2) impaired coronary microvascular function determined by abnormal CFR and/or microvascular resistance.
Another important issue in contemporary practice is how to improve patient prognosis after percutaneous coronary intervention (PCI). Although PCI can induce secondary CMD originated from multiple mechanism associated with the procedure (e.g. distal embolization or endothelial dysfunction), and although secondary CMD also affects coronary circulatory function, there has been no previous evidence evaluating the incidence and prognosis of secondary CMD after successful PCI for epicardial coronary stenosis. Furthermore, both previous and recent trials demonstrated that intravascular imaging-guided PCI optimization has significantly better clinical outcomes than angiography-only guided PCI. However, these trials could not explain the exact mechanism underlying the potential benefit of intravascular imaging-guided PCI optimization for better clinical outcome, aside from a larger final stent area following intravascular imaging-guided PCI. Although the fundamental purpose of PCI is to resolve inducible myocardial ischemia originated from epicardial coronary stenosis, several studies have demonstrated that a substantial proportion of patients who underwent angiographically successful PCI had suboptimal post-PCI FFR or non-hyperemic pressure ratios, which are independently associated with worse clinical outcomes. Previous studies demonstrated that intravascular imaging devices could identify correctable cause of suboptimal post-PCI FFR. In this regard, it can be expected that intravascular imaging-guided PCI optimization would result in better post-PCI physiologic results such as higher post-PCI FFR and CFR, compared with angiography-only guided PCI.
However, these issues have not been fully clarified. Regarding the prognostic impact of CMD, only limited data has been available on the prognostic implications of CMD defined by the universal definition among patients with IHD, especially in patients with insignificant epicardial coronary disease defined by FFR\>0.80. In addition, only one prospective study evaluated optical coherence tomography (OCT)-guided PCI for post-PCI FFR in patients with non-ST segment elevation myocardial infarction. None of prospective study evaluated potential physiologic benefit of intravascular imaging-guided PCI optimization using intravascular ultrasound (IVUS) or OCT in unselected patient population.
Therefore, the primary objectives of the current multicenter prospective registry are to evaluate prognostic implications of CMD in patients with suspected IHD undergoing revascularization decision using FFR or other non-hyperemic pressure ratios and to evaluate the efficacy of intravascular imaging-guided optimization to enhance post-revascularization coronary circulatory function, compared with angiography-only guided revascularization in revascularized population.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1003
- Subject must be ≥18 years
- Patients suspected with IHD
- Patients undergoing physiologic assessment (CFR, IMR, and FFR) for evaluation of severity of CAD
- Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic or imaging evaluation and he/she or his/her legally authorized representative provides written informed consent to any study related procedure.
- Cardiogenic shock (systolic blood pressure <90mmHg or requiring inotropics to maintain blood pressure >90mmHg) or cardiac arrest
- Non-cardiac co-morbid conditions are present with life expectancy <2 year (per site investigator's medical judgment).
- Inability to undergo physiologic assessment (CFR, IMR, and FFR)
- Pregnant or lactating women
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Revascularized Population: Patients treated by intravascular imaging-guided PCI optimization Invasive physiologic assessment Among patients who received PCI, patients whose PCI was optimized through intravascular imaging device (IVUS or OCT). Revascularized Population: Patients treated by intravascular imaging-guided PCI optimization Intravascular imaging Among patients who received PCI, patients whose PCI was optimized through intravascular imaging device (IVUS or OCT). Deferred Population: Patients with preserved microvascular function (CFR≥2.0 OR IMR<25) Invasive physiologic assessment Among patients who did not undergo PCI at the discretion of the operator, patients with preserved microvascular function (CFR≥2.0 OR IMR\<25) in physiologic assessment. Deferred Population: Patients with CMD (CFR<2.0 and IMR≥25) Invasive physiologic assessment Among patients who did not undergo PCI at the discretion of the operator, patients diagnosed CMD (CFR\<2.0, IMR≥25) in physiologic assessment. Revascularized Population: Patients treated by angiography-only guided PCI Invasive physiologic assessment Among patients who received PCI, patients whose PCI was optimized through angiography-only.
- Primary Outcome Measures
Name Time Method Patient-oriented composite outcomes (POCO) 1 year after last patient enrollment a composite of all-cause death, MI, any repeat revascularization, or admission for heart failure
- Secondary Outcome Measures
Name Time Method Non-target vessel MI 1 year after last patient enrollment Non-target vessel MI
Admission for congestive heart failure 1 year after last patient enrollment Admission for congestive heart failure
Seattle Angina Questionnaire Baseline, 1 year, and 2 year after patient enrollment Physical limitation, Angina stability, Angina frequency, Treatment satisfaction, Quality of life
Proportion of functionally optimized post-PCI results Post-procedure Proportion of functionally optimized post-PCI results (Post-PCI FFR\>0.80 and CFR\>2.0) according to the use of intravascular imaging
All-cause death 1 year after last patient enrollment All-cause death
Cardiac death 1 year after last patient enrollment Cardiac death
Target vessel revascularization (ischemia-driven or all) 1 year after last patient enrollment Target vessel revascularization (ischemia-driven or all)
Any repeat revascularization (ischemia-driven or all) 1 year after last patient enrollment Any repeat revascularization (ischemia-driven or all)
Target-vessel MI 1 year after last patient enrollment Target-vessel MI
Any MI 1 year after last patient enrollment Any MI
Non-target vessel revascularization (ischemia-driven or all) 1 year after last patient enrollment Non-target vessel revascularization (ischemia-driven or all)
Stroke (ischemic and hemorrhagic) 1 year after last patient enrollment Stroke (ischemic and hemorrhagic)
Incidence of secondary CMD after PCI Post-procedure Incidence of secondary CMD (CFR\<2.0 and IMR≥25) after PCI among revascularized population
Trial Locations
- Locations (7)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Chosun University Hospital
🇰🇷Gwangju, Korea, Republic of
Gyeongsang National University Hospital
🇰🇷Jinju, Korea, Republic of
Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Seoul National University Boramae Medical Center
🇰🇷Seoul, Korea, Republic of