DSE vs Invasive FFR vs CT-FFR (NON-CULPRIT)

June 15, 2019 updated by: Pál Maurovich-Horvat, Semmelweis University Heart and Vascular Center

Assessment of NOn-culprit Lesions With dobutamiNe Stress eChocardiography, compUted Tomography and Fractional fLow Reserve in Patients With Acute

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hungary
      • Budapest, Hungary, 1122
        • Recruiting
        • Heart And Vascular Center, Semmelweis University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Marton Kolossvary, MD
        • Sub-Investigator:
          • Balint Szilveszter, MD PhD
        • Principal Investigator:
          • Pal Maurovich-Horvat, MD PhD MPH
        • Sub-Investigator:
          • Bela Merkely, MD PhD DSC
    • Pest
      • Budapest, Pest, Hungary, 1106
        • Recruiting
        • Bajcsy-Zsilinszky Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peter Andrassy, MD PhD
        • Sub-Investigator:
          • Balazs Jablonkai, MD
        • Sub-Investigator:
          • Abdelkrim Ahres, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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%.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1 PCI Group
Patients after acute myocardial infarction and at least one moderate stenosis on the non-culprit vessels with positive dobutamine stress echocardiography and positive Fractional Flow Reserve recieving revascularization (PCI or CABG) Drug: Standard of care after acute myocardial infarction
Procedure: Revascularization
PCI or CABG
Group 2 OMT group
Patients after acute myocardial infarction and at least one moderate stenosis on the non-culprit vessels with negative dobutamine stress echocardiography and negative Fractional Flow Reserve or the mismatching cases Standard of care after acute myocardial infarction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute myocardial infarction
Time Frame: From baseline to at least 2 years
Detection of a rise and/or fall of cardiac biomarker values [preferably cardiac troponin (cTn)] with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following: Symptoms of ischaemia. New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundle branch block (LBBB).
From baseline to at least 2 years
Cardiovascular death
Time Frame: From baseline to at least 2 years
Death occurs due to cardiovascular cause
From baseline to at least 2 years
Target vessel revascularization
Time Frame: From baseline to at least 2 years
The Investigated Vessel needs Revascularisation due to angina
From baseline to at least 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance of CT-FFR vs invasive FFR
Time Frame: From baseline to 3 months
Diagnostic performance of CT-FFR as compared to invasive FFR
From baseline to 3 months
Diagnostic performance of CT-FFR vs DSE
Time Frame: From baseline to 3 months
Diagnostic performance of CT-FFR as compared to DSE
From baseline to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University Heart and Vascular Center

Collaborators

Bajcsy-Zsilinszky Hospital

Investigators

  • Principal Investigator: Peter Andrassy, MD PhD, Bajcsy-Zsilinszky Hospital
  • Study Director: Pal Maurovich-Horvat, MD PhD MPH, Heart And Vascular Center, Semmelweis University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2017

Primary Completion (Anticipated)

July 30, 2019

Study Completion (Anticipated)

July 30, 2021

Study Registration Dates

First Submitted

November 7, 2018

First Submitted That Met QC Criteria

June 15, 2019

First Posted (Actual)

June 18, 2019

Study Record Updates

Last Update Posted (Actual)

June 18, 2019

Last Update Submitted That Met QC Criteria

June 15, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NON-CULPRIT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be only shared with the pateints' other physicians

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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