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Completed

NCT Number: NCT04808310

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Center of Cardiology, Cardiology I, university hospital Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quantitative flow ratio

Device

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)

Assessment of angiographic severity of the stenosis

Diagnostic Test

The indication to coronary stent intervention will be based on angiography

Primary outcomes

  1. Patient-oriented combined endpoint (clinical endpoint)

    Time frame: 12 months

    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)

  2. Functional endpoint

    Time frame: Upon randomization and following QFR assessment

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

Secondary outcomes

  1. Seattle angina questionaire summary score

    Time frame: 12 months

    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))

  2. Seattle angina questionaire summary score

    Time frame: 3 months

    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. Unplanned admission

    Time frame: 12 months

    Incidence of unplanned hospital admission for angina

  4. Patient-oriented composite endpoint

    Time frame: 3 months

    Patient-oriented composite endpoint (death, myocardial infarction, unplanned revascularization).

  5. Patient-oriented composite endpoint

    Time frame: 12 months

    Patient-oriented composite endpoint (death, myocardial infarction, unplanned revascularization).

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Acronym: QUOMODO

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Mar 22, 2021
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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