NCT00709670

Brief Summary

The aim of this study is to define the best prognostic strategy for patients presenting suspected acute CORONARY syndrome, between MSCT and stress echocardiography.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
217

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

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

July 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 3, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

September 18, 2013

Status Verified

July 1, 2008

Enrollment Period

3 years

First QC Date

July 2, 2008

Last Update Submit

September 17, 2013

Conditions

Chest Pain

Keywords

MSCTEchocardiographyCoronarographyAcute coronary syndrome without ST segment elevationnormal ECGnormal troponinAcute

Outcome Measures

Primary Outcomes (1)

  • Relative diagnostic accuracy of stress echography and MSCT at presentation of patients with acute chest pain and suspected acute coronary syndrome

    2 days

Secondary Outcomes (3)

  • proportion of AE in patients tested negative at both examinations: death, myocardial infraction, percutaneous coronary intervention, coronary artery bypass graft or readmission for chest pain with coronarography visualizing a stenosis greater than 50%.

    6 months

  • proportions of false positives, the reference method being coronarography.

    2 days

  • proportions of non interpretable or non contributory examinations

    2 days

Study Arms (1)

whole population who receive both tests

EXPERIMENTAL

this arm includes the whole study population who will receive both tests: MSCT and stress echocardiography

Procedure: MSCT and stress echocardiography

Interventions

MSCT and stress echocardiographyPROCEDURE

tests MSCT and stress echocardiography

Also known as: tests MSCT and stress echocardiography
whole population who receive both tests

Eligibility Criteria

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

You may qualify if:

  • chest pain \< 24 hours
  • normal ECG
  • normal troponin I

You may not qualify if:

  • ECG evolution
  • troponin I evolution
  • hemodynamic instability
  • rhythmic instability
  • allergy to iodized contrast products
  • Creatinin \> 150 micromol/L
  • venous capital absence
  • auricular fibrillation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital european Georges pompidou

Paris, 75015, France

Location

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eric DURAND, MD PH

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 2, 2008

First Posted

July 3, 2008

Study Start

September 1, 2008

Primary Completion

September 1, 2011

Study Completion

March 1, 2012

Last Updated

September 18, 2013

Record last verified: 2008-07

Locations

FR(1)