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
  Purpose

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


Condition Intervention
Chest Pain
Procedure: MSCT and stress echocardiography

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: ComParative Diagnostic Study Between MSCT and Stress Echography in Patients Presenting With Suspected Acute Coronary Syndrome Without ST Segment Elevation.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 217
Study Start Date: September 2008
Study Completion Date: March 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: whole population who receive both tests
this arm includes the whole study population who will receive both tests: MSCT and stress echocardiography
Procedure: MSCT and stress echocardiography
tests MSCT and stress echocardiography
Other Name: tests MSCT and stress echocardiography

Detailed Description:

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 %.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00709670

Locations
France
Hospital european Georges pompidou
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Eric DURAND, MD PH Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00709670     History of Changes
Other Study ID Numbers: P070607
Study First Received: July 2, 2008
Last Updated: September 17, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
MSCT
Echocardiography
Coronarography
Acute coronary syndrome without ST segment elevation
normal ECG
normal troponin
Acute

Additional relevant MeSH terms:
Chest Pain
Acute Coronary Syndrome
Pain
Signs and Symptoms
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014