Prospective Study With AMI Patients Undergoing PCI

Heart Failure Clinical Trial

— CardioSAVE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03038360
• Other study ID #: ST0033
• Status: Completed
• Start date: September 10, 2014
• Est. completion date: October 30, 2021

Study information

• Verified date: November 2021
• Source: Firalis SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 620
• Est. completion date: October 30, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Germany	Universitaets Herz Zentrum	Bad Krozingen

Sponsors (2)

Lead Sponsor	Collaborator
Firalis SA	Herz-Zentrums Bad Krozingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left Ventricular Ejection Fraction (LVEF) < 40%	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).	At 6 months after PCI
Secondary	Recovery of regional wall motion	Recovery of regional wall motion measured by cMRI at 6 months	At 6 months after PCI