ComParative Diagnostic Study Between Multislice Computed Tomography (MSCT) and Stress Echography in Coronarin Patients. (PEPSI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00709670
First received: July 2, 2008
Last updated: September 17, 2013
Last verified: July 2008

July 2, 2008
September 17, 2013
September 2008
September 2011   (final data collection date for primary outcome measure)
Relative diagnostic accuracy of stress echography and MSCT at presentation of patients with acute chest pain and suspected acute coronary syndrome [ Time Frame: 2 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00709670 on ClinicalTrials.gov Archive Site
  • 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%. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • proportions of false positives, the reference method being coronarography. [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • proportions of non interpretable or non contributory examinations [ Time Frame: 2 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
ComParative Diagnostic Study Between Multislice Computed Tomography (MSCT) and Stress Echography in Coronarin Patients.
ComParative Diagnostic Study Between MSCT and Stress Echography in Patients Presenting With Suspected Acute Coronary Syndrome Without ST Segment Elevation.

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

Patients presenting with a suspected acute CORONARY syndrome is based on the interrogation, the realization of an electrocardiogram (ECG) and 2 dosages of the cardiac troponin at some hours of interval. However, the ECG and the troponin are frequently normal and this does not absolutely eliminate the diagnosis. In that case, it is at present recommended to practise an effort ECG or a stress imaging, such as echocardiography. Several studies estimated the diagnostic exactness of stress echography for patients presenting a recent chest pain without modification of the ECG nor a rise of the troponin with a sensibility from 71 to 86% and a specificity from 91 to 98%. Recently, several teams estimated the interest of multislice computed tomography (MSCT) in the same population. The MSCT sensibility reported by 2 teams is promising because was found between 91 and 100%. On the other hand, the specificity was appreciably less good : between 76 and 82%. The negative predictive value to MSCT was excellent : between 97 and 100%.The aim of this work is to compare the diagnostic exactness between stress echography and MSCT for patients presenting with a suspected acute coronary syndrome without modification of the ECG nor rise of the troponin. It is about a prospective monocentric diagnostic study concerning 400 patients. The primary end point is the proportion report of true positives in MSCT with regard to stress echocardiography (the main diagnosis is the coronarography). The secondary end points include the proportion of false positives, the non interpretable or non contributory examination rate and especially the proportion of unwanted events in 6 months for the negative patients in both examinations according to a combined criteria including death, myocardial infraction (MI), percutaneous CORONARY intervention (PCI), coronary artery bypass graft (CABG) or readmission for chest pain with coronarography visualizing a stenosis greater than 50 %.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Chest Pain
Procedure: MSCT and stress echocardiography
tests MSCT and stress echocardiography
Other Name: tests MSCT and stress echocardiography
Experimental: whole population who receive both tests
this arm includes the whole study population who will receive both tests: MSCT and stress echocardiography
Intervention: Procedure: MSCT and stress echocardiography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
217
March 2012
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • ECG evolution
  • troponin I evolution
  • hemodynamic instability
  • rhythmic instability
  • allergy to iodized contrast products
  • Creatinin > 150 micromol/L
  • venous capital absence
  • auricular fibrillation
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00709670
P070607
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Eric DURAND, MD PH Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP