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

Primary Purpose

Cardiac Ischemia, Acute Coronary Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Latvia
Study Type
Interventional
Intervention
PCI
Sponsored by
Daugavpils Regional Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Ischemia focused on measuring iFR, Instantaneous wave free ratio, virtual percutaneous coronary intervention, Acute coronary syndrome, Multivessel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Daugavpils Regional HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

iFR-guided

Angiography-guided

Arm Description

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

Standard practice staged angiography-guided PCI

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Segmental myocardial deformation by speckle-tracking echocardiography
Change of segmental myocardial deformation
Health-related Quality of Life
Change in health-related quality of life measured using the EQ-5D-5L questionnaire
Number of Participants with Decline of eGFR
Number of participants with decline of eGFR 30% and more in comparison to the first eGFR

Full Information

First Posted
August 2, 2021
Last Updated
April 25, 2022
Sponsor
Daugavpils Regional Hospital
Collaborators
Riga Stradins University
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1. Study Identification

Unique Protocol Identification Number
NCT05006183
Brief Title
Instantaneous Wave-free Ratio Guidance Strategy Evaluation in the Treatment of Multivessel Acute Coronary Syndrome.
Acronym
iStrategy
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2019 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daugavpils Regional Hospital
Collaborators
Riga Stradins University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Ischemia, Acute Coronary Syndrome
Keywords
iFR, Instantaneous wave free ratio, virtual percutaneous coronary intervention, Acute coronary syndrome, Multivessel

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iFR-guided
Arm Type
Experimental
Arm Description
One-stage, virtually planned, iFR-guided and optimized PCI.
Arm Title
Angiography-guided
Arm Type
Active Comparator
Arm Description
Standard practice staged angiography-guided PCI
Intervention Type
Procedure
Intervention Name(s)
PCI
Intervention Description
Percutaneous coronary intervention with Drug-Eluting Stents
Primary Outcome Measure Information:
Title
PCI-related Major adverse cardiac events (MACE)
Description
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.
Time Frame
Index admission
Title
PCI-related Major adverse cardiac events (MACE)
Description
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.
Time Frame
3 months
Title
PCI-related Major adverse cardiac events (MACE)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Segmental myocardial deformation by speckle-tracking echocardiography
Description
Change of segmental myocardial deformation
Time Frame
Index admission, 3 months and 12 months
Title
Health-related Quality of Life
Description
Change in health-related quality of life measured using the EQ-5D-5L questionnaire
Time Frame
Index admission, 3 months and 12 months
Title
Number of Participants with Decline of eGFR
Description
Number of participants with decline of eGFR 30% and more in comparison to the first eGFR
Time Frame
Index admission, 3 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deniss Vasiljevs, MD
Phone
+37165440858
Email
d.vasiljevs@siadrs.lv
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deniss Vasiljevs, MD
Organizational Affiliation
Daugavpils Regional Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Daugavpils Regional Hospital
City
Daugavpils
ZIP/Postal Code
LV-5417
Country
Latvia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deniss Vasiljevs, MD
Phone
+37165440858
Email
d.vasiljevs@siadrs.lv

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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