Chest PainPEPSINCT00709670
ComParative Diagnostic Study Between Multislice Computed Tomography (MSCT) and Stress Echography in Coronarin Patients.
A study testing MSCT and stress echocardiography in people with Chest Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain
- What is being tested?
- MSCT and stress echocardiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2008to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chest pain < 24 hours
- normal ECG
- normal troponin I
Who cannot join
- ECG evolution
- troponin I evolution
- hemodynamic instability
- rhythmic instability
- allergy to iodized contrast products
- Creatinin > 150 micromol/L
- venous capital absence
- auricular fibrillation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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 %.
- Conditions
- Chest Pain
- Being tested
- MSCT and stress echocardiography
- Keywords
- MSCT, Echocardiography, Coronarography, Acute coronary syndrome without ST segment elevation, normal ECG, normal troponin, Acute
- Medical subject headings
- Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSCT and stress echocardiographyProcedure or surgery
Also called tests MSCT and stress echocardiography
tests MSCT and stress echocardiography
| Study group | Role | What they receive |
|---|---|---|
| whole population who receive both tests | Experimental | this arm includes the whole study population who will receive both tests: MSCT and stress echocardiography Receives: Procedure: MSCT and stress echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative diagnostic accuracy of stress echography and MSCT at presentation of patients with acute chest pain and suspected acute coronary syndrome
Measured: 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%.
Measured: 6 months
proportions of false positives, the reference method being coronarography.
Measured: 2 days
proportions of non interpretable or non contributory examinations
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric DURAND, MD PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709670
- Sponsor's protocol ID
- P070607
- Acronym
- PEPSI
- Status last verified
- Jul 2008
- First submitted
- 2 Jul 2008
- Last updated
- 18 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ComParative Diagnostic Study Between MSCT and Stress Echography in Patients Presenting With Suspected Acute Coronary Syndrome Without ST Segment Elevation.
- ClinicalTrials.gov ID
- NCT00709670
- Acronym / sponsor ID
- PEPSI / P070607
- Conditions
- Chest Pain
- Keywords
- MSCT, Echocardiography, Coronarography, Acute coronary syndrome without ST segment elevation, normal ECG, normal troponin, Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 3 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 %.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| whole population who receive both tests | Experimental | Procedure: MSCT and stress echocardiographythis arm includes the whole study population who will receive both tests: MSCT and stress echocardiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- chest pain < 24 hours
- normal ECG
- normal troponin I
Key exclusion criteria (8 listed)
- ECG evolution
- troponin I evolution
- hemodynamic instability
- rhythmic instability
- allergy to iodized contrast products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSCT and stress echocardiographyAlso: tests MSCT and stress echocardiographytests MSCT and stress echocardiography | Procedure or surgery | whole population who receive both tests |
Primary outcome
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
3 secondary outcomes
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
proportions of false positives, the reference method being coronarography.
Time frame: 2 days
proportions of non interpretable or non contributory examinations
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric DURAND, MD PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MSCT and stress echocardiography in people with Chest Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2013.