Prognostic Value of Cardial Stress Perfusion Imaging

Coronary Artery Disease Clinical Trial

— PROSPERCARS  

Official title:

Prognostic Value of Low Irradiation Cardiac Stress Perfusion Scans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04564794
• Other study ID #: 2020PI174
• Status: Completed
• Start date: December 1, 2022
• Est. completion date: November 26, 2023

Study information

• Verified date: November 2023
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11952
• Est. completion date: November 26, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Locations

Country	Name	City	State
France	Nancy Hospital	Vandœuvre-lès-Nancy	Grand Est

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall mortality	to evaluate the prognostic contribution of low radiation stress myocardial perfusion scintigraphy on overall mortality risk , overall mortality will be calculate	6 months
Secondary	Death from cardiac causes, either proven or suspected (death from unexplained causes),	To evaluate the prognostic contribution of myocardial perfusion scintigraphy of low radiation stress on mortality from cardiac causes.	6 months
Secondary	Major cardiac events (death of proven or suspected cardiac cause, myocardial infarction, myocardial revascularization procedure),	To evaluate the prognostic contribution of myocardial perfusion scintigraphy of low radiation stress on major cardiac events	6 months
Secondary	Cardiac mortality and major cardiac events.	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