免费获得国外相关药品，最快 1 个工作日回馈药物信息
DSE vs Invasive FFR vs CT-FFR (NON-CULPRIT)
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Fractional Flow Reserve | Procedure: Revascularization |
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 |
| Estimated Enrollment : | 100 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Assessment of NOn-culprit Lesions With dobutamiNe Stress eChocardiography, compUted Tomography and Fractional fLow Reserve in Patients With Acute |
| Actual Study Start Date : | March 30, 2017 |
| Estimated Primary Completion Date : | July 30, 2019 |
| Estimated Study Completion Date : | July 30, 2021 |
| 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
|
- 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).
- Cardiovascular death [ Time Frame: From baseline to at least 2 years ]Death occurs due to cardiovascular cause
- Target vessel revascularization [ Time Frame: From baseline to at least 2 years ]The Investigated Vessel needs Revascularisation due to angina
- 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
- Diagnostic performance of CT-FFR vs DSE [ Time Frame: From baseline to 3 months ]Diagnostic performance of CT-FFR as compared to DSE
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Probability Sample |
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)
| Contact: Peter Andrassy, MD PhD | +36302038285 | andrassy22@yahoo.com | |
| Contact: Balazs Jablonkai, MD | +36307584354 | jbalazs89@gmail.com |
| Hungary | |
| Bajcsy-Zsilinszky Hospital | Recruiting |
| Budapest, Pest, Hungary, 1106 | |
| Contact: Peter Andrassy, MD PhD +36302038285 andrassy22@yahoo.com | |
| Contact: Balazs Jablonkai, MD +36307584354 jbalazs89@gmail.com | |
| Principal Investigator: Peter Andrassy, MD PhD | |
| Sub-Investigator: Balazs Jablonkai, MD | |
| Sub-Investigator: Abdelkrim Ahres, MD | |
| Heart and Vascular Center, Semmelweis University | Recruiting |
| Budapest, Hungary, 1122 | |
| Contact: Pál Maurovich-Horvat, MD PhD MPH +36206632485 p.maurovich-horvat@cirg.hu | |
| Contact: Judit Simon, MD +36304897447 juditsimon21@gmail.com | |
| Sub-Investigator: Marton Kolossvary, MD | |
| Sub-Investigator: Balint Szilveszter, MD PhD | |
| Sub-Investigator: Judit Simon, MD | |
| Principal Investigator: Pal Maurovich-Horvat, MD PhD MPH | |
| Sub-Investigator: Bela Merkely, MD PhD DSC | |
| Principal Investigator: | Peter Andrassy, MD PhD | Bajcsy-Zsilinszky Hospital | |
| Study Director: | Pal Maurovich-Horvat, MD PhD MPH | Heart and Vascular Center, Semmelweis University |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | November 7, 2018 | ||||||||
| First Posted Date | June 18, 2019 | ||||||||
| Last Update Posted Date | June 18, 2019 | ||||||||
| Actual Study Start Date | March 30, 2017 | ||||||||
| Estimated Primary Completion Date | July 30, 2019 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
|
||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures |
|
||||||||
| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | 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 | ||||||||
| 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. |
||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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%. | ||||||||
| Condition | Fractional Flow Reserve | ||||||||
| Intervention | Procedure: Revascularization
PCI or CABG
|
||||||||
| Study Groups/Cohorts |
|
||||||||
| Publications * |
|
||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
100 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | July 30, 2021 | ||||||||
| Estimated Primary Completion Date | July 30, 2019 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender |
|
||||||||
| Ages | 18 Years to 80 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Not Provided | ||||||||
| Contacts |
|
||||||||
| Listed Location Countries | Hungary | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03988881 | ||||||||
| Other Study ID Numbers | NON-CULPRIT | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
|
||||||||
| IPD Sharing Statement |
|
||||||||
| Responsible Party | Pál Maurovich-Horvat, Semmelweis University Heart and Vascular Center | ||||||||
| Study Sponsor | Semmelweis University Heart and Vascular Center | ||||||||
| Collaborators | Bajcsy-Zsilinszky Hospital | ||||||||
| Investigators |
|
||||||||
| PRS Account | Semmelweis University Heart and Vascular Center | ||||||||
| Verification Date | June 2019 | ||||||||
