HeartLinc, a Study With AMI Patients Undergoing PCI

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03322436

Acronym

HeartLinc

Enrollment

240

Registered

2017-10-26

Start date

2018-03-13

Completion date

2022-10-31

Last updated

2024-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AMI Patients

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.

Interventions

DIAGNOSTIC_TESTHeartLinc kit

Samples are collected and analyzed afterwards

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

France, South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026