NCT04564794

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,952

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2020

Completed
2.2 years until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

September 21, 2020

Last Update Submit

November 28, 2023

Conditions

Keywords

coronarymyocardial perfusion tomoscintigraphy.

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Death from cardiac causes, either proven or suspected (death from unexplained causes),

    6 months

  • Major cardiac events (death of proven or suspected cardiac cause, myocardial infarction, myocardial revascularization procedure),

    6 months

  • Cardiac mortality and major cardiac events.

    6 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • 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).

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nancy Hospital

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

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Pierre-Yves Marie, MD, PhD

    Nancy CHRU hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical director

Study Record Dates

First Submitted

September 21, 2020

First Posted

September 25, 2020

Study Start

December 1, 2022

Primary Completion

July 1, 2023

Study Completion

November 26, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations