AMI PatientsHeartLincNCT03322436
HeartLinc, a Study With AMI Patients Undergoing PCI
An observational study of AMI Patients, run by Firalis SA at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AMI Patients
- What is being tested?
- HeartLinc kit
- How many people
- 240 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Mar 2018to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: AMI patients undergoing PCI
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Non-interventional Patient Study to Demonstrate Medical Utility of the lncRNA to Predict HF in AMI Patients
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.
- Conditions
- AMI Patients
- Being tested
- HeartLinc kit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartLinc kitDiagnostic test
Samples are collected and analyzed afterwards
| Study group | Role | What they receive |
|---|---|---|
| AMI patients treated by PCI | AMI patient treated by PCI at risk to develop Heart Failure Receives: Diagnostic Test: HeartLinc kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
LV-EF < 40%
Proportion of patients with LV-EF < 40% at 12 months measured by echocardiography
Measured: 12 months
Secondary outcomes (1)
LVEDV
Left Ventricular End Diastolic Volume (LVEDV) at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start13 Mar 2018
- Primary completion30 Jul 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMI PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firalis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hüseyin FIRAT, MD, PhD,, Principal investigator, Firalis SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322436
- Sponsor's protocol ID
- ST0083
- Acronym
- HeartLinc
- Status last verified
- May 2024
- First submitted
- 24 Oct 2017
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Patient Study to Demonstrate Medical Utility of the lncRNA to Predict HF in AMI Patients
- ClinicalTrials.gov ID
- NCT03322436
- Acronym / sponsor ID
- HeartLinc / ST0083
- Conditions
- AMI Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Firalis SAIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 26 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMI patients treated by PCI | – | Diagnostic Test: HeartLinc kitAMI patient treated by PCI at risk to develop Heart Failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- AMI patients undergoing PCI
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeartLinc kitSamples are collected and analyzed afterwards | Diagnostic test | AMI patients treated by PCI |
Primary outcome
LV-EF < 40%
Time frame: 12 months
Proportion of patients with LV-EF < 40% at 12 months measured by echocardiography
1 secondary outcome
LVEDV
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hüseyin FIRAT, MD, PhD, principal investigator
Firalis SA
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AMI Patients, run by Firalis SA at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LV-EF < 40% (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.