HeartLinc, a Study With AMI Patients Undergoing PCI | NCT03322436

Studies
HeartLinc, a Study With AMI Patients Undergoing PCI

NCT03322436

Sponsor

Firalis SA

Status

Completed

Last Update Posted

May 23, 2024Actual

Enrollment

240Actual

Phase

Not provided

Conditions

AMI Patients

Interventions

HeartLinc kit

Countries

France
South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 13, 2018Actual

Primary Completion Date

Jul 30, 2022Actual

Completion Date

Oct 31, 2022Actual

First Submitted Date

Oct 24, 2017

First Submission Date that Met QC Criteria

Oct 25, 2017

First Posted Date

Oct 26, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2024

Last Update Posted Date

May 23, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

240Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AMI patients treated by PCI		AMI patient treated by PCI at risk to develop Heart Failure	Diagnostic Test: HeartLinc kit

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HeartLinc kit	Diagnostic Test	Samples are collected and analyzed afterwards	AMI patients treated by PCI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
LV-EF < 40%	Proportion of patients with LV-EF < 40% at 12 months measured by echocardiography	12 months

Secondary Outcomes

Measure	Description	Time Frame
LVEDV	Left Ventricular End Diastolic Volume (LVEDV) at 12 months	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

AMI patients undergoing PCI

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Hüseyin FIRAT, MD, PhD,	Firalis SA	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
CHU de TOULOUSE		Toulouse		31059	France
SNUH

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided