HeartLinc, a Study With AMI Patients Undergoing PCI

AMI Patients Clinical Trial

— HeartLinc  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03322436
• Other study ID #: ST0083
• Status: Completed
• Start date: March 13, 2018
• Est. completion date: October 31, 2022

Study information

• Verified date: May 2024
• Source: Firalis SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: October 31, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• AMI Patients

Intervention

Diagnostic Test:
• HeartLinc kit
Samples are collected and analyzed afterwards

Locations

Country	Name	City	State
France	CHU de TOULOUSE	Toulouse
Korea, Republic of	SNUH	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Firalis SA

Countries where clinical trial is conducted

France,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LV-EF < 40%	Proportion of patients with LV-EF < 40% at 12 months measured by echocardiography	12 months
Secondary	LVEDV	Left Ventricular End Diastolic Volume (LVEDV) at 12 months	12 months