NCT03322436

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
• Phase: —
• Study type: Observational
• Enrollment: 240 (actual)
• Sponsor: Firalis SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	HeartLinc kit	Samples are collected and analyzed afterwards

Timeline

• Start date: 2018-03-13
• Primary completion: 2022-07-30
• Completion: 2022-10-31
• First posted: 2017-10-26
• Last updated: 2024-05-23

Locations

2 sites across 2 countries: France, South Korea