QUantitative Flow Ratio Or Angiography for the assessMent of nOn-culprit Lesions

Coronary Artery Disease Clinical Trial

— QUOMODO  

Official title:

QUantitative Flow Ratio Or Angiography for the assessMent of nOn-culprit Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04808310
• Other study ID #: 2020-15296
• Status: Recruiting
• Phase: Phase 4
• Start date: October 1, 2020
• Est. completion date: April 17, 2024

Study information

• Verified date: January 2024
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to study whether the use of complex 3-dimensional assessment of the severity of a stenosis improves angina and in general cardiovascular outcomes in patients who have residual intermediate coronary artery stenosis following an acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI). Goals of the study are: - To investigate whether decision-making based on quantitative flow reserve (QFR) is associated with a decrease in angina 3 months after an ACS - To investigate whether use of QFR is associated with an improved prognosis.

Description:

The study is a single-center, randomized superiority trial to compare two strategies for the assessment of the hemodynamic relevance of coronary lesions. The primary analysis will be on the per-protocol principle (i.e. including all patients who are not protocol violators). A separate analysis will be performed on an intention-to-treat basis (i.e. all randomized patients randomized to a treatment arm). Primary endpoint 1. Angina questionnaire Secondary endpoints: Number and % of patients undergoing PCI Seattle Angina Questionnaire - SAQ Physical limitation scale - SAQ angina stability scale - SAQ angina frequency scale - SAQ quality of life - SAQ Treatment Satisfaction Disease perception scale Follow-up (3 and 12 months) - Patient-oriented composite endpoint (death, myocardial infarction, unplanned revascularization) and its components.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 17, 2024
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Successfully treated acute coronary syndrome
• At least one additional intermediate stenosis (>30% and <90%).
• Patient =18 years old

Exclusion Criteria:

• Stenoses or patients a priori not amenable to treatment with PCI (at the discretion of two interventional cardiologists - e.g. patients with limited life expectancy, stenosis in very small vessels, very diffuse disease with complex/very calcified stenosis requiring surgery etc).
• Persistent symptoms or evidence of ischemia requiring intervention of the non-culprit lesion.
• Any contraindication to PCI according to guidelines
• An ACS in the period following the index ACS and randomization
• TIMI (Thrombolysis in Myocardial Infarction) flow grade < 3 in the culprit vessel
• Presence of thrombus in the non-culprit lesion
• Participation in another randomized interventional study interfering with the present protocol
• Patient unable to give informed consent
• Women of child-bearing potential or lactating
• Previous coronary artery bypass surgery CABG
• Recent (within 30 days) unsuccessful PCI
• Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the last 3 months
• Left ventricular ejection fraction <30%
• Severe chronic obstructive pulmonary disease (COPD)
• Severe valvular heart disease
• FFR (or RFR, iFR etc) assessment of non-culprit lesions at the time of the index procedure

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Quantitative flow ratio
Quantitative flow ratio (QFR) is a computer method that estimates the hemodynamic relevance of a coronary stenosis based on three-dimensional quantitative coronary angiography (3D QCA)

Diagnostic Test:
• Assessment of angiographic severity of the stenosis
The indication to coronary stent intervention will be based on angiography

Locations

Country	Name	City	State
Germany	Center of Cardiology, Cardiology I, university hospital Mainz	Mainz	Rheinland-Pfalz

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-oriented combined endpoint (clinical endpoint)	composite of patient-oriented events and significant angina (all-cause death, non fatal myocardial infarction including type 1, 2, 4, unplanned hospitalization for angina or heart failure, unplanned revascularization, SAQ<90)	12 months
Primary	Functional endpoint	Proportion of patients assigned to medical treatment in the two groups (QFR vs. Reference)	Upon randomization and following QFR assessment
Secondary	Seattle angina questionaire summary score	Angina severity as assessed by the Seattle Angina Questionnaire (SAQ, score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life))	12 months
Secondary	Seattle angina questionaire summary score	Angina severity as assessed by the Seattle Angina Questionnaire (SAQ, score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life))	3 months
Secondary	Unplanned admission	Incidence of unplanned hospital admission for angina	12 months
Secondary	Patient-oriented composite endpoint	Patient-oriented composite endpoint (death, myocardial infarction, unplanned revascularization).	3 months
Secondary	Patient-oriented composite endpoint	Patient-oriented composite endpoint (death, myocardial infarction, unplanned revascularization).	12 months