- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03038360
Prospective Study With AMI Patients Undergoing PCI (CardioSAVE)
CardioSAVE: A 12-months Prospective Longitudinal Controlled Study for the Validation of a Novel Predictive Model and a Diagnostic Tool, for the Risk Stratification of AMI Patients Undergoing PCI
Study Overview
Status
Conditions
Detailed Description
Study rational:
Acute Myocardial Infarction (AMI), a common manifestation of coronary artery disease (CAD), is associated with a relatively high incidence and fatality rate. Myocardial Infarction (MI), commonly known as "heart attack", which usually results from an impaired blood supply often caused by thrombus formation in a coronary vessel, resulting in an acute reduction of oxygen supply to a portion of the myocardium. Reperfusion using primary angioplasty through percutaneous coronary intervention (PCI) was proven to be superior to other methods in reducing the fatality rate of the acute phase of the AMI.
During the last decade tremendous efforts have been given to the identification of cardiac biomarkers (BMs) for the diagnosis of AMI. Cardiac BMs have been proven extremely useful in facilitating the diagnostic as well as the timing of therapeutic intervention and in addressing important questions in terms of physiopathology . This resulted in the extensive use of BMs such as troponins in the diagnosis of MI.
Firalis and the Luxembourg general hospital have identified novel biomarkers that could serve as independent risk predictors and prognostic markers for cardiac and clinical complications. First to confirm the value of our identified biomarker panels and to increase their diagnostic/predictive performance, Firalis will identify novel BMs in patient undergoing PCI to include novel biomarkers in this panel and develop a novel early stage prognostic test for clinical outcome in acute myocardial infarction (AMI) patients receiving percutaneous coronary intervention (PCI). This novel test will also be able to monitor treatment response.
For this purpose, the predictive and diagnostic value of the candidate biomarker set have to be clinically validated in a controlled prospective study conducted by the Bad Krozingen Hearth Center. The sample and data collected in this proof of concept study will constitute an independent validation set at the Bad Krozingen Heart Center. Early time point samples will be used to estimate the risk associated with patients and the data obtained will be correlated with the one year outcome of patients.
The development and successful implementation of such diagnostic assay will have strong impact on the quality of care AMI patients, and will significantly reduce costs for healthcare and economy.
Primary objectives:
- To monitor clinical complications registered following PCI, e.g. death, re-infarction and heart failure
- To perform cardiac measurements including electrocardiogram, and left ventricular ejection fraction (LVEF) by cardiac echography and post-AMI myocardium remodelling by cardiac magnetic resonance (CMR) imaging
- To determine the levels of new and exploratory biomarkers in peripheral blood samples collected before and 1 to 3 days after PCI in patients with MI and to correlate them with clinical outcomes.
- To assess the prognostic and diagnostic values of each biomarker or combination of biomarkers prior and shortly (3 and 5 days) after PCI treatment long-term (12 months) clinical outcomes.
Secondary objectives:
- To quantitatively measure reference biomarkers related to cardiac function, including Troponin I/T, CK, CK-MB, BNP, NT-proBNP.
- To correlate the levels of new and exploratory biomarkers with reference biomarkers (Troponin I/T, CK, CK-MB, NT-Pro BNP) and cardiac measurements including electrocardiogram, post-AMI myocardium remodelling by magnetic resonance imaging, and left ventricular ejection fraction (LVEF) by cardiac echography.
- To evaluate the prognostic and diagnostic values of each biomarker or combination with regard to reference biomarkers (Troponin I/T, CK, CK-MB, NT-Pro BNP) as well as the combination of new and reference biomarkers against classical reference biomarkers, and cardiac measurements including regression of ST-segment by electrocardiogram, post-AMI myocardium remodelling by magnetic resonance imaging, and left ventricular ejection fraction (LVEF) by cardiac echography.
Study design:
CardioSAVE is a prospective 12-month controlled longitudinal study in 600 AMI patients, with a one year follow-up conducted by the Bad Krozingen Heart Center. The objectif is to validate a novel predictive model and a diagnostic tool, for the risk stratification of AMI patients undergoing PCI. The sample and data collected by eCRF will allow to set up a prototype personalized medicine device focusing on Heart Failure (HF) induced by AMI. The primary endpoint will be the proportion of patients with left ventricular ejection fraction (LVEF) < 40% at 6 months. The main secondary endpoint is recovery of regional wall motion measured by cMRI at 6 months. Early time point samples, cMRI at day 3 and other clinical patient data will be used to estimate the risk associated with patients and the data obtained will be correlated with the one year outcome of patients.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bad Krozingen, Germany, 79189
- Universitaets Herz Zentrum
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male and Female patients with non childbearing potential (post-menopausal, ovariectomised or hysterectomised) patients. Menopause is defined as > 60 years, or between 45 and 60 years being amenorrheic for at least 2 years
- Age more than 18 years old
Acute myocardial infarction with clinical decision to treat with percutaneous coronary intervention
Primary PCI for myocardial infarction:
- ST-elevation myocardial infarction (STEMI) or
- Large non-ST-elevation myocardial infarction (NSTEMI) with hs-Troponin T ≥ 0,1 ng/mL
- Having signed an Informed Consent to participate in the trial before any study related procedure has been taken.
- Having signed an Informed Consent for Biobank sampling.
Exclusion Criteria:
1. Cardiac arrest, ventricular fibrillation, cardiogenic shock, stent thrombosis, previous AMI, angina within 48h before infarction, previous CABG 3. Severe concomitant non-cardiac illnesses 4. Relevant non-coronary cardiac illnesses 5. Planned major surgery 6. Participated in any investigational drug or therapy study with a non-approved medication, within the previous 3 months 7. Being - dependent on the Investigator or the Sponsor (e.g., including but not limited to affiliated employee)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Left Ventricular Ejection Fraction (LVEF) < 40%
Time Frame: At 6 months after PCI
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Proportion of patients with LV-EF < 40% at 6 months or Death and/or occurence of serious cardiovascular events such as reinfarction, onset of a cardiovascular disease (e.g.
heart failure).
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At 6 months after PCI
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recovery of regional wall motion
Time Frame: At 6 months after PCI
|
Recovery of regional wall motion measured by cMRI at 6 months
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At 6 months after PCI
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Hueseyin Firat, MD, PhD, Firalis SA
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ST0033
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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