Clinical trial NCT05006183: Instantaneous Wave-free Ratio Guidance Strategy Evaluation in the Treatment of Multivessel Acute Coronary Syndrome.
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
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Ischemia
Acute Coronary Syndrome
Keywords: iFR
Instantaneous wave free ratio
virtual percutaneous coronary intervention
Acute coronary syndrome
Multivessel
Lead sponsor: Daugavpils Regional Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Riga Stradins University
First posted: 2021-08-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: PCI-related Major adverse cardiac events (MACE)
timeFrame: Index admission
measure: PCI-related Major adverse cardiac events (MACE)
timeFrame: 3 months
measure: PCI-related Major adverse cardiac events (MACE)
timeFrame: 12 months
Secondary outcomes:
measure: Segmental myocardial deformation by speckle-tracking echocardiography
timeFrame: Index admission, 3 months and 12 months
measure: Health-related Quality of Life
timeFrame: Index admission, 3 months and 12 months
measure: Number of Participants with Decline of eGFR
timeFrame: Index admission, 3 months and 12 months
Other outcomes:
Locations:
city: Daugavpils
country: Latvia
facility: Daugavpils Regional Hospital
Study officials:
affiliation: Daugavpils Regional Hospital
name: Deniss Vasiljevs, MD
role: PRINCIPAL_INVESTIGATOR
References: