ComParative Diagnostic Study Between Multislice Computed Tomography (MSCT) and Stress Echography in Coronarin Patients. (PEPSI)
Primary Purpose
Chest Pain
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MSCT and stress echocardiography
Sponsored by
About this trial
This is an interventional diagnostic trial for Chest Pain focused on measuring MSCT, Echocardiography, Coronarography, Acute coronary syndrome without ST segment elevation, normal ECG, normal troponin, Acute
Eligibility 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
Sites / Locations
- Hospital european Georges pompidou
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
whole population who receive both tests
Arm Description
this arm includes the whole study population who will receive both tests: MSCT and stress echocardiography
Outcomes
Primary Outcome Measures
Relative diagnostic accuracy of stress echography and MSCT at presentation of patients with acute chest pain and suspected acute coronary syndrome
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%.
proportions of false positives, the reference method being coronarography.
proportions of non interpretable or non contributory examinations
Full Information
NCT ID
NCT00709670
First Posted
July 2, 2008
Last Updated
September 17, 2013
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00709670
Brief Title
ComParative Diagnostic Study Between Multislice Computed Tomography (MSCT) and Stress Echography in Coronarin Patients.
Acronym
PEPSI
Official Title
ComParative Diagnostic Study Between MSCT and Stress Echography in Patients Presenting With Suspected Acute Coronary Syndrome Without ST Segment Elevation.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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 %.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain
Keywords
MSCT, Echocardiography, Coronarography, Acute coronary syndrome without ST segment elevation, normal ECG, normal troponin, Acute
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
217 (Actual)
8. Arms, Groups, and Interventions
Arm Title
whole population who receive both tests
Arm Type
Experimental
Arm Description
this arm includes the whole study population who will receive both tests: MSCT and stress echocardiography
Intervention Type
Procedure
Intervention Name(s)
MSCT and stress echocardiography
Other Intervention Name(s)
tests MSCT and stress echocardiography
Intervention Description
tests MSCT and stress echocardiography
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
proportions of false positives, the reference method being coronarography.
Time Frame
2 days
Title
proportions of non interpretable or non contributory examinations
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric DURAND, MD PH
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital european Georges pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
Learn more about this trial
ComParative Diagnostic Study Between Multislice Computed Tomography (MSCT) and Stress Echography in Coronarin Patients.
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