- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04564794
Prognostic Value of Cardial Stress Perfusion Imaging (PROSPERCARS)
Prognostic Value of Low Irradiation Cardiac Stress Perfusion Scans
Stress myocardial perfusion scintigraphy is a reference examination for the detection and monitoring of coronary patients, and this examination has already been the subject of multiple validation studies, including for the stratification of the prognosis of these patients, information that can usefully guide therapeutic choices.
Today, this reduction in the activity of injected radiopharmaceuticals is taking place in a growing number of nuclear medicine departments.
The implications are unknown in terms of the risk of death of the different parameters studied
Study Overview
Status
Conditions
Detailed Description
Stress myocardial perfusion scintigraphy is a reference examination for the detection and monitoring of coronary patients, and this examination has already been the subject of multiple validation studies, including for the stratification of the prognosis of these patients, information that can usefully guide therapeutic choices (medical treatment, myocardial revascularization, ...). The arrival of new solid-state cameras has been a real technological leap for this examination, making it possible to significantly improve the quality of the images and also to drastically reduce the activities of injected radiopharmaceuticals and thus the exposure of patients and staff to ionizing radiation. Today, this reduction in the activity of injected radiopharmaceuticals is taking place in a growing number of nuclear medicine departments. The injected activities are reduced up to a third of those injected in the past (this is indeed the case in the population we propose to study).
However, the value of the prognostic stratification obtained with stress myocardial perfusion scans recorded with low activity on semiconductor cameras is not yet known. In particular, the implications are unknown in terms of the risk of death of the different parameters studied (normal or abnormal examination, extent of myocardial ischemia and infarction sequelae, impact on left ventricular function in post-stress and resting states, etc.).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Anne-Sophie Hue
- Phone Number: +33383153475
- Email: dripromoteur@chru-nancy.fr
Study Locations
-
-
Grand Est
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Vandœuvre-lès-Nancy, Grand Est, France, 54511
- Nancy Hospital
-
Contact:
- Pierre-Yves Marie, PhD
-
Contact:
- Véronique Roch, Master degree
-
Principal Investigator:
- Pierre-Yves Marie, PhD
-
Sub-Investigator:
- Batric Popovic, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Any coronary patient suspected or proven to have had a stress myocardial perfusion tomoscintigraphy performed at the Nancy CHRU and corresponding to a standardized model of expression of results (i.e. more than 10,000 reports).
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall mortality
Time Frame: 6 months
|
to evaluate the prognostic contribution of low radiation stress myocardial perfusion scintigraphy on overall mortality risk , overall mortality will be calculate
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Death from cardiac causes, either proven or suspected (death from unexplained causes),
Time Frame: 6 months
|
To evaluate the prognostic contribution of myocardial perfusion scintigraphy of low radiation stress on mortality from cardiac causes.
|
6 months
|
Major cardiac events (death of proven or suspected cardiac cause, myocardial infarction, myocardial revascularization procedure),
Time Frame: 6 months
|
To evaluate the prognostic contribution of myocardial perfusion scintigraphy of low radiation stress on major cardiac events
|
6 months
|
Cardiac mortality and major cardiac events.
Time Frame: 6 months
|
To evaluate the prognostic contribution of myocardial perfusion scintigraphy of low radiation stress on quality of examination complementary to coronary angiography in a subgroup of approximately 700 patients who had a coronary angiography within ≤ 2 months compared to scintigraphy.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pierre-Yves Marie, MD, PhD, Nancy CHRU hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020PI174
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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