Prognostic Value of Low Irradiation Cardiac Stress Perfusion Scans (PROSPERCARS)

• ClinicalTrials.gov Identifier: NCT04564794
• Recruitment Status: Not yet recruiting
• First Posted: September 25, 2020
• Last Update Posted: September 25, 2020
• Sponsor: Pierre Yves MARIE
• Information provided by (Responsible Party): Pierre Yves MARIE, Central Hospital, Nancy, France

Study Description

Brief 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

Condition or disease
Coronary Artery Disease

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 Design

• Study Type: Observational
• Estimated Enrollment: 10000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Prognostic Value of Low Irradiation Cardiac Stress Perfusion Scans
• Estimated Study Start Date: October 1, 2020
• Estimated Primary Completion Date: July 1, 2021
• Estimated Study Completion Date: August 31, 2021

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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.
2. 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
3. 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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

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).

Criteria

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

Contacts and Locations

Contacts

Contact: Anne-Sophie Hue; +33383153475; dripromoteur@chru-nancy.fr

Locations

France

Nancy Hospital

Vandœuvre-lès-Nancy, Grand Est, France, 54511

Contact: Pierre-Yves Marie, PhD

Contact: Véronique Roch, Master degree

Principal Investigator: Pierre-Yves Marie, PhD

Sub-Investigator: Batric Popovic, MD

Sponsors and Collaborators

Pierre Yves MARIE

Investigators

• Principal Investigator: Pierre-Yves Marie, PhD; Nancy's hospital

More Information

• Responsible Party: Pierre Yves MARIE, PhD, Central Hospital, Nancy, France
• ClinicalTrials.gov Identifier: NCT04564794
• Other Study ID Numbers: 2020PI174
• First Posted: September 25, 2020
• Last Update Posted: September 25, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pierre Yves MARIE, Central Hospital, Nancy, France:

coronary; myocardial perfusion tomoscintigraphy.

Additional relevant MeSH terms:

Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases