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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Coronary Syndrome; Cardiac Ischemia
• Intervention / Treatment: Procedure: PCI

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deniss Vasiljevs, MD; Phone Number: +37165440858; Email: d.vasiljevs@siadrs.lv

Study Locations

• Latvia
  • Daugavpils, Latvia, LV-5417
    • Recruiting
    • Daugavpils Regional Hospital
    • Contact: Deniss Vasiljevs, MD; Phone Number: +37165440858; Email: d.vasiljevs@siadrs.lv

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iFR-guided; One-stage, virtually planned, iFR-guided and optimized PCI.	Procedure: PCI; Percutaneous coronary intervention with Drug-Eluting Stents
Active Comparator: Angiography-guided; Standard practice staged angiography-guided PCI	Procedure: PCI; Percutaneous coronary intervention with Drug-Eluting Stents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Daugavpils Regional Hospital
• Collaborators: Riga Stradins University
• Investigators: Principal Investigator: Deniss Vasiljevs, MD, Daugavpils Regional Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2019
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: August 7, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 25, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Acute coronary syndrome; iFR; Multivessel; Instantaneous wave free ratio; virtual percutaneous coronary intervention
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Syndrome; Ischemia; Acute Coronary Syndrome
• Other Study ID Numbers: SP0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No