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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Angiography | Active Comparator | The indication to further coronary intervention will be based on angiographic diameter stenosis. |
|
| Quantitative flow ratio (QFR) | Experimental | The indication to further coronary intervention will be based on QFR. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantitative flow ratio | Device | Quantitative flow ratio (QFR) is a computer method that estimates the hemodynamic relevance of a coronary stenosis based on three-dimensional quantitative coronary angiography (3D QCA) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Functional endpoint | Proportion of patients assigned to medical treatment in the two groups (QFR vs. Reference) | Upon randomization and following QFR assessment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Seattle angina questionaire summary score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of Cardiology, Cardiology I, university hospital Mainz | Mainz | Rhineland-Palatinate | 55131 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38980329 | Derived | Ullrich-Daub H, Olschewski M, Schnorbus B, Belhadj KA, Kohler T, Vosseler M, Munzel T, Gori T. Quantitative flow ratio or angiography for the assessment of non-culprit lesions in acute coronary syndromes, a randomized trial. Clin Res Cardiol. 2025 Jun;114(6):729-737. doi: 10.1007/s00392-024-02484-5. Epub 2024 Jul 9. | |
| 35445090 | Derived |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Patients will be randomized 1:1 to one of the two study arms. Randomization will be done by using a computer-generated random sequence (Medcalc, Mariakerke, BE).
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Patients and outcome assessors will be blinded to the randomization group.
| Assessment of angiographic severity of the stenosis | Diagnostic Test | The indication to coronary stent intervention will be based on angiography |
|
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 |
| Unplanned admission | Incidence of unplanned hospital admission for angina | 12 months |
| Patient-oriented composite endpoint | Patient-oriented composite endpoint (death, myocardial infarction, unplanned revascularization). | 3 months |
| Patient-oriented composite endpoint | Patient-oriented composite endpoint (death, myocardial infarction, unplanned revascularization). | 12 months |
| Ullrich H, Olschewski M, Belhadj KA, Munzel T, Gori T. Quantitative Flow Ratio or Angiography for the Assessment of Non-culprit Lesions in Acute Coronary Syndromes: Protocol of the Randomized Trial QUOMODO. Front Cardiovasc Med. 2022 Apr 4;9:815434. doi: 10.3389/fcvm.2022.815434. eCollection 2022. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |