Skip to main content
OpenTrials
Completed

NCT Number: NCT03322436

HeartLinc, a Study With AMI Patients Undergoing PCI

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de TOULOUSE, Toulouse, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HeartLinc kit

Diagnostic Test

Samples are collected and analyzed afterwards

Primary outcomes

  1. LV-EF < 40%

    Time frame: 12 months

    Proportion of patients with LV-EF < 40% at 12 months measured by echocardiography

Secondary outcomes

  1. LVEDV

    Time frame: 12 months

    Left Ventricular End Diastolic Volume (LVEDV) at 12 months

Sponsors and collaborators

Lead sponsor

Firalis SA

Industry

Registry information

Official study title

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

Acronym: HeartLinc

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Oct 26, 2017
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.