Heart FailureCardioSAVENCT03038360
Prospective Study With AMI Patients Undergoing PCI
An observational study of Heart Failure, run by Firalis SA at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 620 participants
- Where
- 1 siteGermany
- Study dates
- 10 Sep 2014to 30 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute Myocardial Infarction (AMI) patients undergoing Percutaneous Coronary Intervention (PCI)
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At 6 months after PCI
Secondary outcomes (1)
Recovery of regional wall motion
Recovery of regional wall motion measured by cMRI at 6 months
Measured: At 6 months after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start10 Sep 2014
- Primary completion30 Nov 2020
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 620 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firalis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Herz-Zentrums Bad Krozingen
- Responsible party
- Sponsor
- Investigators
- Hueseyin Firat, MD, PhD, Principal investigator, Firalis SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038360
- Sponsor's protocol ID
- ST0033
- Acronym
- CardioSAVE
- Status last verified
- Nov 2021
- First submitted
- 30 Jan 2017
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03038360
- Acronym / sponsor ID
- CardioSAVE / ST0033
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 620 participants (actual)
- Lead sponsor
- Firalis SAIndustry (pharma, biotech, devices)
- Collaborators
- Herz-Zentrums Bad Krozingen
- Study start
- 10 Sep 2014 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute Myocardial Infarction (AMI) patients undergoing Percutaneous Coronary Intervention (PCI)
Key inclusion criteria (8 listed)
- 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
- 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.
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Left Ventricular Ejection Fraction (LVEF) < 40%
Time frame: At 6 months after PCI
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).
1 secondary outcome
Recovery of regional wall motion
Time frame: At 6 months after PCI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hueseyin Firat, MD, PhD principal investigator
Firalis SA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Firalis SA at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Ejection Fraction (LVEF) < 40% (time frame: At 6 months after PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.