Prospective Study With AMI Patients Undergoing PCI

NCT03038360 | Completed DMC

• 1 other identifier: ST0033
• Study Type: observational
• Target: 620
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Recovery of regional wall motion

  At 6 months after PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Acute Myocardial Infarction (AMI) patients undergoing Percutaneous Coronary Intervention (PCI)

You may qualify if:

• 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.

You may not qualify if:

• \. 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)

Sponsors & Collaborators

• Firalis SA: lead
• Herz-Zentrums Bad Krozingen: collaborator

Study Sites (1)

Universitaets Herz Zentrum

Bad Krozingen, 79189, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine samples

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Hueseyin Firat, MD, PhD

  Firalis SA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: January 31, 2017
• Study Start: September 10, 2014
• Primary Completion: November 30, 2020
• Study Completion: October 30, 2021
• Last Updated: May 23, 2023

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)