QUantitative Flow Ratio Or Angiography for the assessMent of nOn-culprit Lesions
- Conditions
- Coronary Artery Disease
- Interventions
- Diagnostic Test: Assessment of angiographic severity of the stenosisDevice: Quantitative flow ratio
- Registration Number
- NCT04808310
- Lead Sponsor
- Johannes Gutenberg University Mainz
- Brief Summary
The aim of this study is to study whether the use of complex 3-dimensional assessment of the severity of a stenosis improves angina and in general cardiovascular outcomes in patients who have residual intermediate coronary artery stenosis following an acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI).
Goals of the study are:
* To investigate whether decision-making based on quantitative flow reserve (QFR) is associated with a decrease in angina 3 months after an ACS
* To investigate whether use of QFR is associated with an improved prognosis.
- Detailed Description
The study is a single-center, randomized superiority trial to compare two strategies for the assessment of the hemodynamic relevance of coronary lesions.
The primary analysis will be on the per-protocol principle (i.e. including all patients who are not protocol violators). A separate analysis will be performed on an intention-to-treat basis (i.e. all randomized patients randomized to a treatment arm).
Primary endpoint 1. Angina questionnaire
Secondary endpoints:
Number and % of patients undergoing PCI
Seattle Angina Questionnaire
* SAQ Physical limitation scale
* SAQ angina stability scale
* SAQ angina frequency scale
* SAQ quality of life
* SAQ Treatment Satisfaction Disease perception scale Follow-up (3 and 12 months) - Patient-oriented composite endpoint (death, myocardial infarction, unplanned revascularization) and its components.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Successfully treated acute coronary syndrome
- At least one additional intermediate stenosis (>30% and <90%).
- Patient ≥18 years old
- Stenoses or patients a priori not amenable to treatment with PCI (at the discretion of two interventional cardiologists - e.g. patients with limited life expectancy, stenosis in very small vessels, very diffuse disease with complex/very calcified stenosis requiring surgery etc).
- Persistent symptoms or evidence of ischemia requiring intervention of the non-culprit lesion.
- Any contraindication to PCI according to guidelines
- An ACS in the period following the index ACS and randomization
- TIMI (Thrombolysis in Myocardial Infarction) flow grade < 3 in the culprit vessel
- Presence of thrombus in the non-culprit lesion
- Participation in another randomized interventional study interfering with the present protocol
- Patient unable to give informed consent
- Women of child-bearing potential or lactating
- Previous coronary artery bypass surgery CABG
- Recent (within 30 days) unsuccessful PCI
- Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the last 3 months
- Left ventricular ejection fraction <30%
- Severe chronic obstructive pulmonary disease (COPD)
- Severe valvular heart disease
- FFR (or RFR, iFR etc) assessment of non-culprit lesions at the time of the index procedure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Angiography Assessment of angiographic severity of the stenosis The indication to further coronary intervention will be based on angiographic diameter stenosis. Quantitative flow ratio (QFR) Quantitative flow ratio The indication to further coronary intervention will be based on QFR.
- Primary Outcome Measures
Name Time Method Patient-oriented combined endpoint (clinical endpoint) 12 months composite of patient-oriented events and significant angina (all-cause death, non fatal myocardial infarction including type 1, 2, 4, unplanned hospitalization for angina or heart failure, unplanned revascularization, SAQ\<90)
Functional endpoint Upon randomization and following QFR assessment Proportion of patients assigned to medical treatment in the two groups (QFR vs. Reference)
- Secondary Outcome Measures
Name Time Method Seattle angina questionaire summary score 3 months Angina severity as assessed by the Seattle Angina Questionnaire (SAQ, score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life))
Unplanned admission 12 months Incidence of unplanned hospital admission for angina
Patient-oriented composite endpoint 12 months Patient-oriented composite endpoint (death, myocardial infarction, unplanned revascularization).
Trial Locations
- Locations (1)
Center of Cardiology, Cardiology I, university hospital Mainz
🇩🇪Mainz, Rheinland-Pfalz, Germany