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

NCT04808310 | Completed Phase 4

• 1 other identifier: 2020-15296
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Seattle angina questionaire summary score

  12 months

• Seattle angina questionaire summary score

  3 months

• Unplanned admission

  12 months

• Patient-oriented composite endpoint

  3 months

• Patient-oriented composite endpoint

  12 months

Study Arms (2)

Angiography

ACTIVE COMPARATOR

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

Diagnostic Test: Assessment of angiographic severity of the stenosis

Quantitative flow ratio (QFR)

EXPERIMENTAL

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

Device: Quantitative flow ratio

Interventions

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)

Quantitative flow ratio (QFR)

Assessment of angiographic severity of the stenosis DIAGNOSTIC_TEST

The indication to coronary stent intervention will be based on angiography

Angiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Study Sites (1)

Center of Cardiology, Cardiology I, university hospital Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Related Publications (2)

• Ullrich-Daub H, Olschewski M, Schnorbus B, Belhadj KA, Kohler T, Vosseler M, Munzel T, Gori T. Quantitative flow ratio or angiography for the assessment of non-culprit lesions in acute coronary syndromes, a randomized trial. Clin Res Cardiol. 2025 Jun;114(6):729-737. doi: 10.1007/s00392-024-02484-5. Epub 2024 Jul 9.

  PMID: 38980329 DERIVED

• 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.

  PMID: 35445090 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and outcome assessors will be blinded to the randomization group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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).

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 22, 2021
• Study Start: October 1, 2020
• Primary Completion: April 1, 2023
• Study Completion: April 17, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)