NCT02822638

Brief Summary

Ischemic heart disease is the leading cause of mortality in industrialized countries. ST elevated acute myocardial infarction is one of its most frequent and deadly manifestation. In the last 20 years, STEMI mortality has been reduced by 50% with the advent of timely reperfusion (primary percutaneous intervention) and significant progression in pharmacologic intervention. However, death and heart failure incidence after STEMI remain elevated: up to 20% at one year. Also, therapeutic management following international guidelines is standardized toward a "one-size fits all" therapeutic management. In order to continue improving myocardial infarction outcomes, there is a need to better understand and individualize therapeutic targets such myocardial reperfusion injury, post reperfusion inflammation, adverse left ventricular (LV) remodeling …. This knowledge will allow us to propose new therapeutic strategies and in the long run strive towards personalized medicine. The aim objective of this cohort of STEMI patients is to identify new biological markers of injury and prognosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,204

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2016

Completed
Last Updated

July 4, 2016

Status Verified

June 1, 2016

Enrollment Period

6.8 years

First QC Date

June 30, 2016

Last Update Submit

June 30, 2016

Conditions

Myocardial Infarction

Keywords

Myocardial infarctionbiomarkersSTEMI

Outcome Measures

Primary Outcomes (2)

  • Change in Troponin

    Dosage of Troponin at hospital admission and 4 hours after Percutaneous coronary intervention (PCI)

    Day 0

  • Change in Creatine Kinase

    Dosage of Creatine Kinase at hospital admission and 4 hours after PCI

    Day 0

Secondary Outcomes (2)

  • New York Heart Association (NYHA) Class

    at admission (Day 0)

  • Left ventricular ejection fraction (LVEF)

    24 hours after PCI (Day 1)

Study Arms (1)

STEMI PATIENT Cohort

STEMI PATIENT Cohort

Other: STEMI PATIENT Cohort

Interventions

STEMI PATIENT CohortOTHER

PCI

STEMI PATIENT Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

STEMI PATIENT

You may qualify if:

  • Age\> 18 years
  • Diagnosis of STEMI defined by ST segment elevation ≥ 0.2 mV in 2 contiguous leads on a 12-lead ECG.
  • Primary PCI within 12 hours of symptoms onset.

You may not qualify if:

  • Diagnosis of STEMI not confirmed by angiography
  • Refusal to participate in the study or to sign the consent
  • Inability to give information to the subject about the study
  • Lack of medical social coverage
  • Deprivation of civil rights

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Cardiovasculaire Louis Pradel 28, Avenue du Doyen Lépine

Bron, 69677, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

In STEMI patient refered for PCI at Louis Pradel Hospital, blood samples were taken on admission at (H0) and 4h after reperfusion. To constitute the serum bank of our STEMI cohort, samples were collected the same time as the blood tests done routinely. These additional samples were be centrifuged and treated and stored in a collection of biological samples of total serum and plasma and blood at the Biological Resource Center of HCL Neurobiotec at -80 ° C (DC- 2008-72, AC-2013-1867 certified NFS96900 FR13-018140).

MeSH Terms

Conditions

Myocardial InfarctionST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Michel OVIZE, Pr

    Centre d'investigation Clinique , Hôpital Cardiovasculaire Louis Pradel 28, Avenue du Doyen Lépine - 69677 BRON

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2016

First Posted

July 4, 2016

Study Start

August 1, 2009

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

July 4, 2016

Record last verified: 2016-06

Locations

FR(1)