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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: Assessment of angiographic severity of the stenosis; Device: Quantitative flow ratio

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • Center of Cardiology, Cardiology I, university hospital Mainz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Angiography; The indication to further coronary intervention will be based on angiographic diameter stenosis.	Diagnostic test: Assessment of angiographic severity of the stenosis; The indication to coronary stent intervention will be based on angiography
Experimental: Quantitative flow ratio (QFR); The indication to further coronary intervention will be based on QFR.	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Functional endpoint	Proportion of patients assigned to medical treatment in the two groups (QFR vs. Reference)	Upon randomization and following QFR assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-oriented composite endpoint	Patient-oriented composite endpoint (death, myocardial infarction, unplanned revascularization).	3 months
Patient-oriented composite endpoint	Patient-oriented composite endpoint (death, myocardial infarction, unplanned revascularization).	12 months
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
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
Unplanned admission	Incidence of unplanned hospital admission for angina	12 months

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz

Publications and helpful links

General Publications

• Ullrich H, Olschewski M, Belhadj KA, Munzel T, Gori T. Quantitative Flow Ratio or Angiography for the Assessment of Non-culprit Lesions in Acute Coronary Syndromes: Protocol of the Randomized Trial QUOMODO. Front Cardiovasc Med. 2022 Apr 4;9:815434. doi: 10.3389/fcvm.2022.815434. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): April 17, 2024

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 6, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 2020-15296

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No