Clinical trial NCT04808310: QUantitative Flow Ratio Or Angiography for the assessMent of nOn-culprit Lesions
Official title: QUantitative Flow Ratio Or Angiography for the assessMent of nOn-culprit Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patient-oriented combined endpoint (clinical endpoint)
timeFrame: 12 months
measure: Functional endpoint
timeFrame: Upon randomization and following QFR assessment
Secondary outcomes:
measure: Seattle angina questionaire summary score
timeFrame: 12 months
measure: Seattle angina questionaire summary score
timeFrame: 3 months
measure: Unplanned admission
timeFrame: 12 months
measure: Patient-oriented composite endpoint
timeFrame: 3 months
measure: Patient-oriented composite endpoint
timeFrame: 12 months
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Center of Cardiology, Cardiology I, university hospital Mainz
state: Rheinland-Pfalz
Study officials:
References:
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.