HeartLinc, a Study With AMI Patients Undergoing PCI (HeartLinc)

A Non-interventional Patient Study to Demonstrate Medical Utility of the lncRNA to Predict HF in AMI Patients

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.

Study Overview

• Status: Completed
• Conditions: AMI Patients
• Intervention / Treatment: Diagnostic test: HeartLinc kit

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.

• Study Type: Observational
• Enrollment (Actual): 240

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • CHU de Toulouse
• Korea, Republic of
  • Seoul, Korea, Republic of
    • SNUH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

AMI patients undergoing PCI

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AMI patients treated by PCI; AMI patient treated by PCI at risk to develop Heart Failure	Diagnostic test: HeartLinc kit; Samples are collected and analyzed afterwards

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LV-EF < 40%	Proportion of patients with LV-EF < 40% at 12 months measured by echocardiography	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LVEDV	Left Ventricular End Diastolic Volume (LVEDV) at 12 months	12 months

Collaborators and Investigators

• Sponsor: Firalis SA
• Investigators: Principal Investigator: Hüseyin FIRAT, MD, PhD,, Firalis SA

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2018
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: October 24, 2017
• First Submitted That Met QC Criteria: October 25, 2017
• First Posted (Actual): October 26, 2017

Study Record Updates

• Last Update Posted (Actual): May 23, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ST0083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No