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CompletedNCT03322436HeartLincUpdated May 23, 2024

HeartLinc, a Study With AMI Patients Undergoing PCI

An observational study in AMI Patients, sponsored by Firalis SA. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-23.

Sponsored by Firalis SA · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
240
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • AMI Patients
03

In context

Lead sponsor

Firalis SA is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

AMI patients undergoing PCI

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 for Heartlink study participation and consent to participate in the ancillary Heartlink 2 study

Exclusion criteria

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 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
240 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • AMI patients treated by PCI

    AMI patient treated by PCI at risk to develop Heart Failure

    Diagnostic Test: HeartLinc kit

Interventions

  • Diagnostic testHeartLinc kit

    Samples are collected and analyzed afterwards

06

What researchers measure

Primary outcomes

  1. LV-EF < 40%

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

    Time frame: 12 months

Secondary outcomes

  1. LVEDV

    Left Ventricular End Diastolic Volume (LVEDV) at 12 months

    Time frame: 12 months

07

Study locations

2 sites
  • CHU de TOULOUSE
    Toulouse, 31059, France
  • SNUH
    Seoul, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2018 to primary completion in Jul 2022, 52 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 24, 2017
First posted
Oct 26, 2017
StartActual
Mar 13, 2018
Primary completionActual
Jul 30, 2022
CompletionActual
Oct 31, 2022
Last update
May 23, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03322436
Lead sponsor
Firalis SA
Responsible party
Sponsor
First posted
Oct 26, 2017
Start date
Mar 13, 2018
Primary completion
Jul 30, 2022
Completion
Oct 31, 2022
Last update
May 23, 2024

Study contacts

Hüseyin FIRAT, MD, PhD,
principal investigator · Firalis SA

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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