HeartLinc, a Study With AMI Patients Undergoing PCI

Firalis

Status: Completed

Conditions: AMI Patients

Treatments: Diagnostic Test: HeartLinc kit

Study type: Observational

Funder types: Industry

Identifiers

NCT03322436

ST0083

Details and patient eligibility

About

HeartLinc is a non-interventional patient study to demonstrate medical utility of the lncRNA to predict HF in AMI patients. 300 patients are expected to be recruited.

Full description

The recruiting phase of the study includes the recruitment of patients (36 months) and is followed by 12 month of monitoring for each patient. After deciding MI and PCI treatment by physical exam, ECG and other diagnostic methods, blood samples will be collected. After undergoing PCI, samples of the same patients will be collected during hospitalization days after PCI (D0-3) according to the patient study flowchart. After hospitalization, patients will be contacted by phone call or written questionary after 30 days (D30). After 6 and 12 months, patients are reinvited for a routine rehospitalisation to perform clinical exams and ECGs. Blood and urine samples will be collected after 12 months.

Enrollment: 240 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 18 years
• Myocardial infarction in association with a recent acute coronary syndrome <24 hrs leading to a coronary angioplasty decision
• Myocardial infarction with ST-elevation (STEMI) or myocardial infarction following acute coronary syndrome without ST-segment shift with a significant elevation of non-ST troponin (NSTEMI)
• Participation in the Hearlink Cohort
• Collecting and signed informed consent for Heartlink study participation and consent to participate in the ancillary Heartlink 2 study

Exclusion criteria

• Sudden Cardiac arrest which resulted in resuscitation other than single, non-repeated electric shock,
• cardiogenic shock
• Severe extra-cardiac diseases involving the short-term life expectancy of patients (risk of death at one year
• Programmed major non-cardiac surgery
• Known Altered Left Ventricular function before Acute Coronary Syndrome inclusion
• History of left, right or global heart failure
• Significant heart failure at hospital admittance (KILLIP 2)
• Acute Coronary Syndrome know more than 24 hours
• History of Myocardial infarction
• Participation in any other in progress or stopped study for less than 3 months other than the Heartlink study

Trial design

240 participants in 1 patient group

AMI patients treated by PCI

Description:

AMI patient treated by PCI at risk to develop Heart Failure

Treatment:

Diagnostic Test: HeartLinc kit