Coronary Artery Disease Clinical Trial
— QUOMODOOfficial title:
QUantitative Flow Ratio Or Angiography for the assessMent of nOn-culprit Lesions
Verified date | January 2024 |
Source | Johannes Gutenberg University Mainz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | April 17, 2024 |
Est. primary completion date | April 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Successfully treated acute coronary syndrome - At least one additional intermediate stenosis (>30% and <90%). - Patient =18 years old Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Center of Cardiology, Cardiology I, university hospital Mainz | Mainz | Rheinland-Pfalz |
Lead Sponsor | Collaborator |
---|---|
Johannes Gutenberg University Mainz |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient-oriented combined endpoint (clinical endpoint) | 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) | 12 months | |
Primary | Functional endpoint | Proportion of patients assigned to medical treatment in the two groups (QFR vs. Reference) | Upon randomization and following QFR assessment | |
Secondary | Seattle angina questionaire summary score | 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)) | 12 months | |
Secondary | Seattle angina questionaire summary score | 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)) | 3 months | |
Secondary | Unplanned admission | Incidence of unplanned hospital admission for angina | 12 months | |
Secondary | Patient-oriented composite endpoint | Patient-oriented composite endpoint (death, myocardial infarction, unplanned revascularization). | 3 months | |
Secondary | Patient-oriented composite endpoint | Patient-oriented composite endpoint (death, myocardial infarction, unplanned revascularization). | 12 months |
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