Clinical trial NCT03988881: DSE vs Invasive FFR vs CT-FFR
Official title: Assessment of NOn-culprit Lesions With dobutamiNe Stress eChocardiography, compUted Tomography and Fractional fLow Reserve in Patients With Acute
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fractional Flow Reserve
Keywords: Dobutamine stress echocardiography
Fractional flow reserve
Computed tomography-fractional flow reserve
Non-culprit lesions
Myocardial infarction
Lesion specific ischemia
Lead sponsor: Semmelweis University Heart and Vascular Center
Sponsor class: OTHER
Collaborators: name: Bajcsy-Zsilinszky Hospital
First posted: 2019-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who suffered acute MI and have at least one non/culprit leasion with a stenosis between 40-80%.

Brief summary: Data are limited regarding the optimal treatment of the non-culprit lesions (NCL) after myocardial infarction (MI). The NON-CULPRIT study is a prospective cohort study with a primary aim to compare invasive fractional flow reserve (FFR) and dobutamine stress echocardiography (DSE) for the evaluation and treatment of NCL in patients with MI.

As a secondary aim the investigators will assess the diagnostic performance of CT derived FFR as compared to invasive FFR and DSE measurements.

Detailed description: Myocardial ischemia and coronary artery disease (CAD) burden both provide valuable prognostic information for adverse cardiac events. More than 50% of patients with acute myocardial infarction have multi-vessel coronary artery disease. However current evidence regarding the optimal treatment of the non-culprit lesions (NCL) after myocardial infarction (MI) is still limited.

The revascularization of NCL with at least moderate severity is associated with improved clinical outcomes, if significant ischemia was detected previously. Currently, there is no strict recommendation on the methods for detecting ischemia, therefore the current study aims to compare Dobutamine stress echocardiography (DSE) and invasive FFR for the evaluation and management of patients with MI and multi-vessel disease.

DSE and FFR measurements will be perfomed in patinets with at least one intermediate NCL. If both results are positive (new wall motion abnormality of at least two segments related to the examined coronary artery on DSE and FFR≤0,8 are declared as positive), stent implantation will be performed, if both results are negative or in case of mismatch, optimal medical treatment will be chosen.

Recent studies demonstrated the discrepancy between anatomical severity and hemodynamic relevance. Invasive fractional flow reserve (FFR) has emerged as the gold standard technique for the detection of lesion specific ischemia. The utilization of FFR in stable and acute chest pain patients can help in the selection of proper treatment strategy. The recently published Compare-Acute and DANAMI-Primulti trials have shown that in STEMI patients FFR-guided complete revascularization of NCL is beneficial as compared to infarct related lesion revascularization only.

However, in light of recent studies involving post-MI patients, invasive FFR might be limited for the assessment of NCL due to vessel remodeling, microvascular changes and altered hemodynamics.

Recent advancements in CT imaging allows for improved image quality and novel post-processing algorithms. Beyond anatomical data, functional information using coronary CT angiography (CTA) dataset and computational fluid dynamics simulations can be derived. CT derived FFR allows for the functional assessment of CAD in a non-invasive fashion.

Data regarding the diagnostic accuracy of CT-FFR as compared to other widely utilized functional tests are limited. Also, high-risk plaque features might affect lesion specific ischemia as detected by invasive FFR. Coronary CTA plus CT-FFR may help to identify patients requiring revascularization, even with controversial DSE and FFR results.

Eligibility criteria: Inclusion Criteria:

* Acute myocardial infarction
* Moderate (40-80 %) stenosis of a non-culprit coronary artery
* Signed informed consent

Exclusion Criteria:

* Age under 18 years
* Age over 80 years
* Incurable malignant disease
* Patients for whom coronary CTA is contraindicated (History of severe and/or anaphylactic contrast reaction, severe renal insufficiency, inability to cooperate with scan acquisition and/or breathhold instructions)

Primary outcomes:
measure: Acute myocardial infarction
timeFrame: From baseline to at least 2 years
measure: Cardiovascular death
timeFrame: From baseline to at least 2 years
measure: Target vessel revascularization
timeFrame: From baseline to at least 2 years
Secondary outcomes:
measure: Diagnostic performance of CT-FFR vs invasive FFR
timeFrame: From baseline to 3 months
measure: Diagnostic performance of CT-FFR vs DSE
timeFrame: From baseline to 3 months
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinszky Hospital
state: Pest
city: Budapest
country: Hungary
facility: Heart and Vascular Center, Semmelweis University
Study officials:
affiliation: Bajcsy-Zsilinszky Hospital
name: Peter Andrassy, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart and Vascular Center, Semmelweis University
name: Pal Maurovich-Horvat, MD PhD MPH
role: STUDY_DIRECTOR
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