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

Acute Coronary Syndrome Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05006183
• Other study ID #: SP0001
• Status: Recruiting
• Phase: N/A
• Start date: August 8, 2019
• Est. completion date: September 2024

Study information

• Verified date: April 2022
• Source: Daugavpils Regional Hospital
• Contact: Deniss Vasiljevs, MD
• Phone: +37165440858
• Email: d.vasiljevs[@]siadrs.lv
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2024
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Cardiac Ischemia
• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia
• Syndrome

Intervention

Procedure:
• PCI
Percutaneous coronary intervention with Drug-Eluting Stents

Locations

Country	Name	City	State
Latvia	Daugavpils Regional Hospital	Daugavpils

Sponsors (2)

Lead Sponsor	Collaborator
Daugavpils Regional Hospital	Riga Stradins University

Country where clinical trial is conducted

Latvia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Segmental myocardial deformation by speckle-tracking echocardiography	Change of segmental myocardial deformation	Index admission, 3 months and 12 months
Secondary	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
Secondary	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