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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05006183
Other study ID # SP0001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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