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

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.

Study Overview

• Status: Completed
• Conditions: Chest Pain
• Intervention / Treatment: Procedure: 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 %.

• Study Type: Interventional
• Enrollment (Actual): 217
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Hospital european Georges pompidou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: tests MSCT and stress echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Relative diagnostic accuracy of stress echography and MSCT at presentation of patients with acute chest pain and suspected acute coronary syndrome	2 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Eric DURAND, MD PH, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: July 2, 2008
• First Submitted That Met QC Criteria: July 2, 2008
• First Posted (Estimate): July 3, 2008

Study Record Updates

• Last Update Posted (Estimate): September 18, 2013
• Last Update Submitted That Met QC Criteria: September 17, 2013
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: Echocardiography; Acute; MSCT; Coronarography; Acute coronary syndrome without ST segment elevation; normal ECG; normal troponin
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Acute Coronary Syndrome
• Other Study ID Numbers: P070607