Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-24 @ 5:43 PM
Study NCT ID:
NCT05877768
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-26
First Post:
2023-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of PCD-CT Based Image Parameters in the Assessment and Quantification of Coronary Artery Disease
Sponsor:
University Medical Center Mainz
Organization:
Study Overview
Official Title:
PCD-CT Registry: Evaluation of Photon Counting Detector-CT Based Image Parameters in the Assessment and Quantification of Coronary Artery Disease (EPIPHANY)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPIPHANY
Brief Summary:
The goal of this observational study is to learn about a new type of computed tomography (Photon-Counting Detector CT) in patients with coronary artery disease.
The main questions it aims to answer are:
* How good is the image quality for the new CT
* How accurate are measurements in the images of the new CT
* Is there a relationship between measurements in the images and the management of the disease (e.g. new medication or additional investigations)
* Is there a relationship between measurements in the images and the results of follow-up investigations
* Is there a relationship between measurements in the images and the patient outcome
Participants will undergo normal clinical assessment of coronary artery disease and all data from the CT scan and additional investigations will be collected. There will be no additional investigations for the purpose of the study. After 1, 2 and 5 years, participants will be asked to answer a health questionaire.
The main questions it aims to answer are:
* How good is the image quality for the new CT
* How accurate are measurements in the images of the new CT
* Is there a relationship between measurements in the images and the management of the disease (e.g. new medication or additional investigations)
* Is there a relationship between measurements in the images and the results of follow-up investigations
* Is there a relationship between measurements in the images and the patient outcome
Participants will undergo normal clinical assessment of coronary artery disease and all data from the CT scan and additional investigations will be collected. There will be no additional investigations for the purpose of the study. After 1, 2 and 5 years, participants will be asked to answer a health questionaire.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: