Instantaneous Wave-free Ratio Guidance Strategy Evaluation in the Treatment of Multivessel Acute Coronary Syndrome.

Not Applicable

Recruiting

• Conditions: Acute Coronary Syndrome; Cardiac Ischemia
• Interventions: Procedure: PCI

• Registration Number: NCT05006183
• Lead Sponsor: Daugavpils Regional Hospital

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.

Study Timeline

• Study Start: 2019-08-08
• Study First Submitted: 2021-08-02
• Study First Submitted QC: 2021-08-07
• Study First Posted: 2021-08-16
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-25
• Last Update Posted: 2022-04-29
• Primary Completion: 2023-08
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iFR-guided	PCI	One-stage, virtually planned, iFR-guided and optimized PCI.
Angiography-guided	PCI	Standard practice staged angiography-guided PCI

Primary Outcome Measures

Name	Time	Method
PCI-related Major adverse cardiac events (MACE)	12 months	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Daugavpils Regional Hospital; 🇱🇻 Daugavpils, Latvia