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

NCT05877768 | Not Yet Recruiting

• 1 other identifier: PCD-CT Registry
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiac Events

  Composite endpoint: major adverse cardiovascular event (MACE); defined as at least one of the following: cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke.

  From inclusion to a maximum follow-up of 5 years

Secondary Outcomes (43)

• Objective Image Noise of Photon-Counting Detector Coronary Computed Tomography Angiography (PCD-CCTA)

  during the PCD-CCTA examination

• Objective Assessment of Noise-Power Spectra of PCD-CCTA

  during the PCD-CCTA examination

• Subjective Image Noise of PCD-CCTA

  during the PCD-CCTA examination

• Objective Vessel sharpness in PCD-CCTA

  during the PCD-CCTA examination

• Subjective Vessel sharpness in PCD-CCTA

  during the PCD-CCTA examination

Study Arms (1)

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.

Diagnostic Test: Photon Counting Detector Coronary Computed Tomography Angiography

Interventions

Photon Counting Detector Coronary Computed Tomography Angiography DIAGNOSTIC_TEST

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

Also known as: Photon-Counting Detector CT (Naeotom Alpha, Siemens Healthineers)

Coronary Artery Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population screened for inclusion criteria will be patients referred for CCTA for suspected coronary artery disease and those with known coronary artery disease and the suspicion of progressive disease.

You may qualify if:

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

You may not qualify if:

• Contraindications preventing the execution of the CCTA (e.g., pregnancy)

Sponsors & Collaborators

• University Medical Center Mainz: lead

Study Sites (1)

University Medical Center Mainz

Mainz, Rhineland-Palatinate, 55116, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Tilman Emrich, MD

  University Medical Center Mainz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tilman Emrich, MD

CONTACT

+49613117; Tilman.Emrich@unimedizin-mainz.de

Moritz C Halfmann, MD

CONTACT

+49613117; Moritz.Halfmann@unimedizin-mainz.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 26, 2023
• Study Start: June 30, 2023
• Primary Completion (Estimated): June 30, 2033
• Study Completion (Estimated): June 30, 2033
• Last Updated: May 26, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)