Acute Coronary Syndrome, Cardiac Ischemia
Conditions
Keywords
iFR, Instantaneous wave free ratio, virtual percutaneous coronary intervention, Acute coronary syndrome, Multivessel
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREPCI
Percutaneous coronary intervention with Drug-Eluting Stents
Sponsors
Riga Stradins University
Daugavpils Regional Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PCI-related Major adverse cardiac events (MACE) | Index admission | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Segmental myocardial deformation by speckle-tracking echocardiography | Index admission, 3 months and 12 months | Change of segmental myocardial deformation |
| Health-related Quality of Life | Index admission, 3 months and 12 months | Change in health-related quality of life measured using the EQ-5D-5L questionnaire |
| Number of Participants with Decline of eGFR | Index admission, 3 months and 12 months | Number of participants with decline of eGFR 30% and more in comparison to the first eGFR |
Countries
Latvia
Contacts
Primary ContactDeniss Vasiljevs, MD
Outcome results
None listed