NCT00623272

Brief Summary

compare measurements of left ventricular volumes and LVEF obtained by 2DE, 3DE, and CMR after a ST elevation myocardial infarction (STEMI) complicated by systolic left ventricular dysfunction

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2008

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

First Submitted

Initial submission to the registry

February 14, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 26, 2008

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

August 24, 2015

Status Verified

June 1, 2008

Enrollment Period

1.4 years

First QC Date

February 14, 2008

Last Update Submit

August 21, 2015

Conditions

Acute Myocardial Infarction

Keywords

The assessment of left ventricular ejection fraction (LVEF)

Outcome Measures

Primary Outcomes (1)

  • compare measurements of left ventricular volumes and LVEF obtained by 2DE, 3DE, and CMR after a ST elevation myocardial infarction (STEMI) complicated by systolic left ventricular dysfunction.

    3 MONTHS

Interventions

compare measurements of left ventricular volumes and LVEF (by Cardiac Magnetic Resonance and Echocardiography)OTHER

To compare measurements of left ventricular volumes and LVEF obtained by 2DE, 3DE, and CMR after a ST elevation myocardial infarction (STEMI) complicated by systolic left ventricular dysfunction.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All the patients presenting a first ischemic clinical episode for at least 30 minutes, associated with one known gap will be included in a forward-looking and consecutive way, of at least 0.1mV in at least two peripheral diversions of the same territory or of at least 0.2 mV in at least two precordial diversions of the same territory
  • An initial FEVG (measured by echocardiography or ventricular angiography in the daytime of the admittance)

You may not qualify if:

  • Age \< 18 years
  • Antecedents of IDM
  • Contraindications in the MRI (claustrophobia, stimulating and defibrillators heart patient implantable, metal intraocular brightness, allergy in the gadolinium, the severe renal insufficiency with clearance in the creatinine ≤30 mL/min)
  • Fibrillation little finger
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Timone's hospital

Marseille, 13, France

Location

Study Officials

  • franck THUNY, MD

    Assistance Publique des Hôpitaux de Marseille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2008

First Posted

February 26, 2008

Study Start

November 1, 2008

Primary Completion

April 1, 2010

Study Completion

July 1, 2010

Last Updated

August 24, 2015

Record last verified: 2008-06

Locations

FR(1)