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
1 other identifier
observational
240
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2018
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2017
CompletedFirst Posted
Study publicly available on registry
October 26, 2017
CompletedStudy Start
First participant enrolled
March 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2022
CompletedMay 23, 2024
May 1, 2024
4.4 years
October 24, 2017
May 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
LV-EF < 40%
Proportion of patients with LV-EF \< 40% at 12 months measured by echocardiography
12 months
Secondary Outcomes (1)
LVEDV
12 months
Study Arms (1)
AMI patients treated by PCI
AMI patient treated by PCI at risk to develop Heart Failure
Interventions
Samples are collected and analyzed afterwards
Eligibility Criteria
AMI patients undergoing PCI
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Firalis SAlead
Study Sites (2)
CHU de TOULOUSE
Toulouse, 31059, France
SNUH
Seoul, South Korea
Biospecimen
Blood and urine samples
Study Officials
- PRINCIPAL INVESTIGATOR
Hüseyin FIRAT, MD, PhD,
Firalis SA
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2017
First Posted
October 26, 2017
Study Start
March 13, 2018
Primary Completion
July 30, 2022
Study Completion
October 31, 2022
Last Updated
May 23, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share