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

NCT ID: NCT05006183

Last Updated: 2022-04-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-08
• Study Completion Date: 2024-09-30

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.

Conditions

Cardiac Ischemia; Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

iFR-guided

One-stage, virtually planned, iFR-guided and optimized PCI.

Group Type: EXPERIMENTAL

PCI

Intervention Type: PROCEDURE

Percutaneous coronary intervention with Drug-Eluting Stents

Angiography-guided

Standard practice staged angiography-guided PCI

Group Type: ACTIVE_COMPARATOR

PCI

Intervention Type: PROCEDURE

Percutaneous coronary intervention with Drug-Eluting Stents

Interventions

PCI

Percutaneous coronary intervention with Drug-Eluting Stents

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riga Stradins University

OTHER

Sponsor Role: collaborator

Daugavpils Regional Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Deniss Vasiljevs

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deniss Vasiljevs, MD

Role: PRINCIPAL_INVESTIGATOR

Daugavpils Regional Hospital

Locations

Daugavpils Regional Hospital

Daugavpils, , Latvia

Site Status: RECRUITING

Countries

Latvia

Central Contacts

Deniss Vasiljevs, MD

Role: CONTACT

d.vasiljevs@siadrs.lv

+37165440858

Facility Contacts

Deniss Vasiljevs, MD

Role: primary

d.vasiljevs@siadrs.lv

+37165440858

Other Identifiers

SP0001

Identifier Type: -

Identifier Source: org_study_id