Acute Coronary Syndrome Clinical Trial
— iStrategyOfficial title:
Characterization of Coronary Artery Hemodynamic Measurements and Virtual Angioplasty Planning by Instantaneous Wave-free Ratio (iFR) in Multivessel Acute Coronary Syndrome Patients With Evaluation of the Impact on Clinical Outcomes.
NCT number | NCT05006183 |
Other study ID # | SP0001 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 8, 2019 |
Est. completion date | September 2024 |
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | September 2024 |
Est. primary completion date | August 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 years of age and older - willing to give informed consent - hemodynamically stable de novo acute coronary syndrome patients with a stenosis of 50% and more by visual estimation in at least two separate coronary arteries - adequate coronary flow, Thrombolysis in Myocardial Infarction (TIMI) flow = 2 - sinus rhythm Exclusion Criteria: - inability to give consent; - younger than 18 years of age - atrial fibrillation rhythm at the time of inclusion - with significant valve disease - in cardiogenic shock - with reduced kidney function - eGFR < 30 (mL/min/1.73m2); - with congenital heart defects - with acute pulmonary artery embolism; - with isolated left main ostial stenosis; - on active oncologic treatment or toxic cardiomyopathy; - revascularization by PCI is not possible due to other comorbidities or patient denial of treatment. |
Country | Name | City | State |
---|---|---|---|
Latvia | Daugavpils Regional Hospital | Daugavpils |
Lead Sponsor | Collaborator |
---|---|
Daugavpils Regional Hospital | Riga Stradins University |
Latvia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Secondary | Segmental myocardial deformation by speckle-tracking echocardiography | Change of segmental myocardial deformation | Index admission, 3 months and 12 months | |
Secondary | Health-related Quality of Life | Change in health-related quality of life measured using the EQ-5D-5L questionnaire | Index admission, 3 months and 12 months | |
Secondary | 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 |
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