Clinical trial NCT03038360: Prospective Study With AMI Patients Undergoing PCI
Official title: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Firalis SA
Sponsor class: INDUSTRY
Collaborators: name: Herz-Zentrums Bad Krozingen
First posted: 2017-01-31
Enrollment: 620
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acute Myocardial Infarction (AMI) patients undergoing Percutaneous Coronary Intervention (PCI)

Brief summary: CardioSAVE is a prospective 12-month controlled longitudinal study for the validation of a novel predictive model and a diagnostic tool, for the risk stratification of AMI patients undergoing PCI, with a one year follow-up.

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.

Eligibility criteria: Inclusion Criteria:

1. 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
2. Age more than 18 years old
3. 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
4. Having signed an Informed Consent to participate in the trial before any study related procedure has been taken.
5. 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)

Primary outcomes:
measure: Left Ventricular Ejection Fraction (LVEF) < 40%
timeFrame: At 6 months after PCI
Secondary outcomes:
measure: Recovery of regional wall motion
timeFrame: At 6 months after PCI
Other outcomes:
Locations:
city: Bad Krozingen
country: Germany
facility: Universitaets Herz Zentrum
Study officials:
affiliation: Firalis SA
name: Hueseyin Firat, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: