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| Name | Class |
|---|---|
| Riga Stradins University | OTHER |
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A single-center, prospective, randomized, open-label, blinded end-point clinical trial of instantaneous wave-free ratio (iFR) guidance strategy impact on clinical outcomes in multivessel acute coronary syndrome (ACS) patients.
The "all-comers" study population consists of hemodynamically stable de novo ACS patients with a stenosis of 50% and more by visual estimation in at least two separate coronary arteries with Thrombolysis in Myocardial Infarction (TIMI) flow ≥ 2 and willing to sign a patient informed consent. ACS diagnosis established by angina pectoris symptoms and/or ECG changes and/or hs-troponin I levels. The use of drug-eluting stents is mandatory in both treatment groups. In the intervention strategy group, patients are treated by the iFR-guided percutaneous coronary intervention (PCI) in one stage. In the control group, patients are treated in accordance with the standard practice of angiography-guided staged approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iFR-guided | Experimental | One-stage, virtually planned, iFR-guided and optimized PCI. |
|
| Angiography-guided | Active Comparator | Standard practice staged angiography-guided PCI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCI | Procedure | Percutaneous coronary intervention with Drug-Eluting Stents |
|
| Measure | Description | Time Frame |
|---|---|---|
| PCI-related Major adverse cardiac events (MACE) | Composite of cardiac death, non-fatal myocardial infarction, unplanned revascularization, stent thrombosis, flow limiting coronary dissections, no-reflow phenomenon, coronary perforations, coronary distal embolization, vascular access site complications requiring blood transfusion or surgical intervention and contrast-induced nephropathy requiring hospitalisation. | Index admission |
| PCI-related Major adverse cardiac events (MACE) | Composite of cardiac death, non-fatal myocardial infarction, unplanned revascularization, stent thrombosis, flow limiting coronary dissections, no-reflow phenomenon, coronary perforations, coronary distal embolization, vascular access site complications requiring blood transfusion or surgical intervention and contrast-induced nephropathy requiring hospitalisation. | 3 months |
| PCI-related Major adverse cardiac events (MACE) | Composite of cardiac death, non-fatal myocardial infarction, unplanned revascularization, stent thrombosis, flow limiting coronary dissections, no-reflow phenomenon, coronary perforations, coronary distal embolization, vascular access site complications requiring blood transfusion or surgical intervention and contrast-induced nephropathy requiring hospitalisation. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Segmental myocardial deformation by speckle-tracking echocardiography | Change of segmental myocardial deformation | Index admission, 3 months and 12 months |
| Health-related Quality of Life | Change in health-related quality of life measured using the EQ-5D-5L questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deniss Vasiljevs, MD | Contact | +37165440858 | d.vasiljevs@siadrs.lv |
| Name | Affiliation | Role |
|---|---|---|
| Deniss Vasiljevs, MD | Daugavpils Regional Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daugavpils Regional Hospital | Recruiting | Daugavpils | LV-5417 | Latvia |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Index admission, 3 months and 12 months |
| Number of Participants with Decline of eGFR | Number of participants with decline of eGFR 30% and more in comparison to the first eGFR | Index admission, 3 months and 12 months |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |