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

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Quantitative flow ratio
Assessment of angiographic severity of the stenosis
Sponsored by
Johannes Gutenberg University Mainz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center of Cardiology, Cardiology I, university hospital MainzRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Angiography

Quantitative flow ratio (QFR)

Arm Description

The indication to further coronary intervention will be based on angiographic diameter stenosis.

The indication to further coronary intervention will be based on QFR.

Outcomes

Primary Outcome Measures

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)
Functional endpoint
Proportion of patients assigned to medical treatment in the two groups (QFR vs. Reference)

Secondary Outcome Measures

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))
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))
Unplanned admission
Incidence of unplanned hospital admission for angina
Patient-oriented composite endpoint
Patient-oriented composite endpoint (death, myocardial infarction, unplanned revascularization).
Patient-oriented composite endpoint
Patient-oriented composite endpoint (death, myocardial infarction, unplanned revascularization).

Full Information

First Posted
March 17, 2021
Last Updated
May 5, 2023
Sponsor
Johannes Gutenberg University Mainz
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1. Study Identification

Unique Protocol Identification Number
NCT04808310
Brief Title
QUantitative Flow Ratio Or Angiography for the assessMent of nOn-culprit Lesions
Acronym
QUOMODO
Official Title
QUantitative Flow Ratio Or Angiography for the assessMent of nOn-culprit Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 17, 2021 (Actual)
Primary Completion Date
March 17, 2024 (Anticipated)
Study Completion Date
March 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johannes Gutenberg University Mainz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized 1:1 to one of the two study arms. Randomization will be done by using a computer-generated random sequence (Medcalc, Mariakerke, BE).
Masking
ParticipantOutcomes Assessor
Masking Description
Patients and outcome assessors will be blinded to the randomization group.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Angiography
Arm Type
Active Comparator
Arm Description
The indication to further coronary intervention will be based on angiographic diameter stenosis.
Arm Title
Quantitative flow ratio (QFR)
Arm Type
Experimental
Arm Description
The indication to further coronary intervention will be based on QFR.
Intervention Type
Device
Intervention Name(s)
Quantitative flow ratio
Intervention Description
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)
Intervention Type
Diagnostic Test
Intervention Name(s)
Assessment of angiographic severity of the stenosis
Intervention Description
The indication to coronary stent intervention will be based on angiography
Primary Outcome Measure Information:
Title
Patient-oriented combined endpoint (clinical endpoint)
Description
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)
Time Frame
12 months
Title
Functional endpoint
Description
Proportion of patients assigned to medical treatment in the two groups (QFR vs. Reference)
Time Frame
Upon randomization and following QFR assessment
Secondary Outcome Measure Information:
Title
Seattle angina questionaire summary score
Description
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))
Time Frame
12 months
Title
Seattle angina questionaire summary score
Description
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))
Time Frame
3 months
Title
Unplanned admission
Description
Incidence of unplanned hospital admission for angina
Time Frame
12 months
Title
Patient-oriented composite endpoint
Description
Patient-oriented composite endpoint (death, myocardial infarction, unplanned revascularization).
Time Frame
3 months
Title
Patient-oriented composite endpoint
Description
Patient-oriented composite endpoint (death, myocardial infarction, unplanned revascularization).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Center of Cardiology, Cardiology I, university hospital Mainz
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tommaso Gori, Prof Dr, PhD
Phone
+49 (0) 6131 17 2729
Email
tommaso.gori@unimedizin-mainz.de
First Name & Middle Initial & Last Name & Degree
Tommaso Gori, Prof Dr, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35445090
Citation
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.
Results Reference
derived

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

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