HeartLinc, a Study With AMI Patients Undergoing PCI

NCT ID: NCT03322436

Last Updated: 2024-05-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-13
• Study Completion Date: 2022-10-31

Brief Summary

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.

Detailed 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.

Conditions

AMI Patients

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

AMI patients treated by PCI

AMI patient treated by PCI at risk to develop Heart Failure

HeartLinc kit

Intervention Type: DIAGNOSTIC_TEST

Samples are collected and analyzed afterwards

Interventions

HeartLinc kit

Samples are collected and analyzed afterwards

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Firalis SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hüseyin FIRAT, MD, PhD,

Role: PRINCIPAL_INVESTIGATOR

Firalis SA

Locations

CHU de TOULOUSE

Toulouse, , France

SNUH

Seoul, , South Korea

Countries

France; South Korea

Other Identifiers

ST0083

Identifier Type: -

Identifier Source: org_study_id