Evaluation of PCD-CT Based Image Parameters in the Assessment and Quantification of Coronary Artery Disease

NCT ID: NCT05877768

Last Updated: 2023-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-30

Study Completion Date

2033-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Coronary Artery Disease

Patients with suspected coronary artery disease and those with known coronary artery disease and the suspicion of progressive disease who undergo clinically indicated Coronary Computed Tomography Angiography on the Photon-Counting Detector CT will be enrolled after written consent. All data from the CT scan and potential additional investigations (e.g. invasive coronary angiographies) 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.

Photon Counting Detector Coronary Computed Tomography Angiography

Intervention Type DIAGNOSTIC_TEST

Clinically indicated Photon Counting Detector Coronary Computed Tomography Angiography for the suspicion of coronary artery disease or the progression thereof.

Interventions

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Photon Counting Detector Coronary Computed Tomography Angiography

Clinically indicated Photon Counting Detector Coronary Computed Tomography Angiography for the suspicion of coronary artery disease or the progression thereof.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Photon-Counting Detector CT (Naeotom Alpha, Siemens Healthineers)

Eligibility Criteria

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Inclusion Criteria

* Clinical indication for a coronary computed tomography angiography (CCTA) for the suspicion of coronary artery disease or the progression thereof
* Written informed consent

Exclusion Criteria

* Contraindications preventing the execution of the CCTA (e.g., pregnancy)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Mainz

OTHER

Sponsor Role lead

Responsible Party

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Tilman Emrich

Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tilman Emrich, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Mainz

Locations

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University Medical Center Mainz

Mainz, Rhineland-Palatinate, Germany

Site Status

Countries

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Germany

Central Contacts

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Tilman Emrich, MD

Role: CONTACT

+49613117 ext. 7358

Moritz C Halfmann, MD

Role: CONTACT

+49613117 ext. 5719

Facility Contacts

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Tilman Emrich, MD

Role: primary

+49613117 ext. 7358

Moritz C Halfmann, MD

Role: backup

+49613117 ext. 5719

Other Identifiers

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PCD-CT Registry

Identifier Type: -

Identifier Source: org_study_id

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