NCT05006183

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

April 29, 2022

Status Verified

April 1, 2022

Enrollment Period

4 years

First QC Date

August 2, 2021

Last Update Submit

April 25, 2022

Conditions

Cardiac IschemiaAcute Coronary Syndrome

Keywords

iFRInstantaneous wave free ratiovirtual percutaneous coronary interventionAcute coronary syndromeMultivessel

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Segmental myocardial deformation by speckle-tracking echocardiography

    Index admission, 3 months and 12 months

  • Health-related Quality of Life

    Index admission, 3 months and 12 months

  • Number of Participants with Decline of eGFR

    Index admission, 3 months and 12 months

Study Arms (2)

iFR-guided

EXPERIMENTAL

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

Procedure: PCI

Angiography-guided

ACTIVE COMPARATOR

Standard practice staged angiography-guided PCI

Procedure: PCI

Interventions

PCIPROCEDURE

Percutaneous coronary intervention with Drug-Eluting Stents

Angiography-guidediFR-guided

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • inability to give consent;
  • younger than 18 years of age
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daugavpils Regional Hospital

Daugavpils, LV-5417, Latvia

RECRUITING

MeSH Terms

Conditions

Coronary Artery DiseaseAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Deniss Vasiljevs, MD

    Daugavpils Regional Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Deniss Vasiljevs, MD

CONTACT

+37165440858d.vasiljevs@siadrs.lv

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 2, 2021

First Posted

August 16, 2021

Study Start

August 8, 2019

Primary Completion

August 1, 2023

Study Completion

September 1, 2024

Last Updated

April 29, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

LA(1)