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Completed

NCT Number: NCT04564794

Prognostic Value of Cardial Stress Perfusion Imaging

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Nancy Hospital

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

About this study

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.).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Prognostic Value of Low Irradiation Cardiac Stress Perfusion Scans

Acronym: PROSPERCARS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 25, 2020
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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