Coronary Artery DiseaseEPIPHANYNCT05877768
Evaluation of PCD-CT Based Image Parameters in the Assessment and Quantification of Coronary Artery Disease
An observational study of Coronary Artery Disease, run by University Medical Center Mainz at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Photon Counting Detector Coronary Computed Tomography Angiography
- How many people
- 3,000 participants
- Where
- 1 siteGermany
- Study dates
- 30 Jun 2023to 30 Jun 2033
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Clinical indication for a coronary computed tomography angiography (CCTA) for the suspicion of coronary artery disease or the progression thereof
- Written informed consent
Who cannot join
- Contraindications preventing the execution of the CCTA (e.g., pregnancy)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
University Medical Center Mainz
Mainz, Rhineland-Palatinate, 55116
Tilman Emrich, MD, +49613117 ext. 7358, Tilman.Emrich@unimedizin-mainz.de
Moritz C Halfmann, MD, +49613117 ext. 5719, Moritz.Halfmann@unimedizin-mainz.de
About this study
Official title: PCD-CT Registry: Evaluation of Photon Counting Detector-CT Based Image Parameters in the Assessment and Quantification of Coronary Artery Disease (EPIPHANY)
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:
Read more
- 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
- Being tested
- Photon Counting Detector Coronary Computed Tomography Angiography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photon Counting Detector Coronary Computed Tomography AngiographyDiagnostic test
Also called Photon-Counting Detector CT (Naeotom Alpha, Siemens Healthineers)
Clinically indicated Photon Counting Detector Coronary Computed Tomography Angiography for the suspicion of coronary artery disease or the progression thereof.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Photon Counting Detector Coronary Computed Tomography Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Image Noise of PCD-CCTA measured objectively using measurements of CT values (HU).
Measured: during the PCD-CCTA examination
Objective Assessment of Noise-Power Spectra of PCD-CCTA
Image Noise of PCD-CCTA measured objectively using noise-power spectra (W/Hz).
Measured: during the PCD-CCTA examination
Subjective Image Noise of PCD-CCTA
Image Noise of PCD-CCTA judged subjectively on a 5-point Likert scale.
Measured: during the PCD-CCTA examination
Objective Vessel sharpness in PCD-CCTA
Vessel sharpness in PCD-CCTA measured objectively using the slope of fitted double sigmoid curves (1/mm)
Measured: during the PCD-CCTA examination
Subjective Vessel sharpness in PCD-CCTA
Vessel sharpness in PCD-CCTA judged subjectively on a 5-point Likert scale.
Measured: during the PCD-CCTA examination
Objective Image Quality in PCD-CCTA
Objective Image Quality in PCD-CCTA measured objectively by contrast-to-noise ratio (HU/HU)
Measured: during the PCD-CCTA examination
Subjective Image Quality in PCD-CCTA
Subjective Image Quality in PCD-CCTA judged subjectively on a 5-point Likert scale.
Measured: during the PCD-CCTA examination
Influence of BMI on image quality of the PCD-CCTA
Influence of Body Mass Index (BMI, kg/m^2) on image quality of the PCD-CCTA
Measured: during the PCD-CCTA examination
Influence of biological sex on image quality of the PCD-CCTA
Influence of patients biological sex (male/female) on image quality of the PCD-CCTA
Measured: during the PCD-CCTA examination
Influence of monoenergetic energy levels on image quality of the PCD-CCTA
Influence of monoenergetic energy levels (keV) on image quality of the PCD-CCTA
Measured: during the PCD-CCTA examination
Influence of slice thickness of reconstruction on image quality of the PCD-CCTA
Influence of slice thickness of reconstruction (mm) on image quality of the PCD-CCTA
Measured: during the PCD-CCTA examination
Influence of reconstruction kernel on image quality of the PCD-CCTA
Influence of reconstruction kernel (Bv/Br/Qr) on image quality of the PCD-CCTA
Measured: during the PCD-CCTA examination
Influence of kernel sharpness level on image quality of the PCD-CCTA
Influence of kernel sharpness level (40-90) on image quality of the PCD-CCTA
Measured: during the PCD-CCTA examination
Influence of radiation dose on image quality of the PCD-CCTA
Influence of radiation dose (mGy) on image quality of the PCD-CCTA
Measured: during the PCD-CCTA examination
Influence of the patients heart rate on image quality of the PCD-CCTA
Influence of the patients maximum, minimum and average heart rate (1/min) on image quality of the PCD-CCTA
Measured: during the PCD-CCTA examination
Influence of the acquisition type on image quality of the PCD-CCTA
Influence of the acquisition type (Sequential, Spiral, Ultra-High Resolution, Spectral) on image quality of the PCD-CCTA
Measured: during the PCD-CCTA examination
Quantitative analysis of Coronary Calcium Scoring from PCD-CCTA
Quantitative analysis of Coronary Calcium volume (mm^3), mass (g) and resulting score according to the Agatston classification.
Measured: during the PCD-CCTA examination
Analysis of Stenosis Classification from PCD-CCTA
Analysis of Coronary stenosis classification according to the Coronary Artery Disease-Reporting and Data System (CAD-RADS, 0-5, higher numbers indicating more severe stenosis).
Measured: during the PCD-CCTA examination
Quantitative analysis of Coronary Diameter Stenoses from PCD-CCTA
Quantitative analysis of Coronary Diameter Stenoses (%) from PCD-CCTA
Measured: during the PCD-CCTA examination
Quantitative analysis of Coronary Area Stenoses from PCD-CCTA
Quantitative analysis of Coronary Area Stenoses (%) from PCD-CCTA
Measured: during the PCD-CCTA examination
Quantitative analysis of computed Fractional Flow Reserve from PCD-CCTA
Quantitative analysis of computed Fractional Flow Reserve (absolute number) from PCD-CCTA.
Measured: during the PCD-CCTA examination
Quantitative analysis of myocardial density from PCD-CCTA
Quantitative analysis of myocardial density (HU) from PCD-CCTA.
Measured: during the PCD-CCTA examination
Quantitative analysis of myocardial iodine content from PCD-CCTA
Quantitative analysis of myocardial iodine content (µg/cm^3) from PCD-CCTA.
Measured: during the PCD-CCTA examination
Quantitative analysis of extracellular volume fraction from PCD-CCTA
Quantitative analysis of the extracellular volume fraction (%) from PCD-CCTA.
Measured: during the PCD-CCTA examination
Influence of BMI on quantitative parameters of the PCD-CCTA
Influence of Body Mass Index (BMI, kg/m^2) on quantitative parameters of the PCD-CCTA
Measured: during the PCD-CCTA examination
Influence of biological sex on quantitative parameters of the PCD-CCTA
Influence of patients biological sex (male/female) on quantitative parameters of the PCD-CCTA
Measured: during the PCD-CCTA examination
Influence of monoenergetic energy levels on quantitative parameters of the PCD-CCTA
Influence of monoenergetic energy levels (keV) on quantitative parameters of the PCD-CCTA
Measured: during the PCD-CCTA examination
Influence of slice thickness of reconstruction on quantitative parameters of the PCD-CCTA
Influence of slice thickness of reconstruction (mm) on quantitative parameters of the PCD-CCTA
Measured: during the PCD-CCTA examination
Influence of reconstruction kernel on quantitative parameters of the PCD-CCTA
Influence of reconstruction kernel (Bv/Br/Qr) on quantitative parameters of the PCD-CCTA
Measured: during the PCD-CCTA examination
Influence of kernel sharpness level on quantitative parameters of the PCD-CCTA
Influence of kernel sharpness level (40-90) on quantitative parameters of the PCD-CCTA
Measured: during the PCD-CCTA examination
Influence of radiation dose on quantitative parameters of the PCD-CCTA
Influence of radiation dose (mGy) on quantitative parameters of the PCD-CCTA
Measured: during the PCD-CCTA examination
Influence of the patients heart rate on quantitative parameters of the PCD-CCTA
Influence of the patients maximum, minimum and average heart rate (1/min) on quantitative parameters of the PCD-CCTA
Measured: during the PCD-CCTA examination
Influence of the acquisition type on quantitative parameters of the PCD-CCTA
Influence of the acquisition type (Sequential, Spiral, Ultra-High Resolution, Spectral) on quantitative parameters of the PCD-CCTA
Measured: during the PCD-CCTA examination
Rates of patients undergoing further cardiac diagnostics
Rates of patients undergoing further cardiac diagnostics, such as additional CT or Invasive Coronary Angiography (ICA), Electrocardiography (ECG), Exercise ECG, Echo, Stress Echo, Magnetic Resonance Imaging (MRI) within 3 months following PCD-CCTA (defined as: related to these tests) and more than 3 months after PCD-CCTA until follow-up (unrelated to these tests).
Measured: 2 weeks after initial PCD-CCTA, 1-year follow-up, 2-year follow-up and final follow-up up to a max of 5 years
Rates of patients undergoing cardiac interventions
Cardiac interventions such as coronary revascularization by ICA, coronary artery bypass grafting (CABG), Valve replacement (operatively and interventional), other cardiothoracic surgeries, implantation of an cardioverter/defibrillator or cardiac resynchronization device, ablation, others
Measured: 2 weeks after initial PCD-CCTA, 1-year follow-up, 2-year follow-up and final follow-up up to a max of 5 years
Correlation and agreement of quantitative measurements from PCD-CCTA with ICA
Correlation and agreement of percent diameter stenosis quantification by PCD-CCTA in comparison to quantitative assessment from ICA.
Measured: ICA within 3 months of initial PCD-CCTA
Correlation and agreement of non-invasive Fractional Flow Reserve from PCD-CCTA with invasive Fractional Flow Reserve from ICA
Correlation and agreement of non-invasively estimated Fractional Flow Reserve by Computed Tomography with invasive Fractional Flow Reserve
Measured: ICA within 3 months of initial PCD-CCTA
Correlation and agreement of Percent diameter stenosis measurement from PCD-CCTA with Fractional Flow Reserve from ICA
Correlation and agreement of stenosis quantification by PCD-CCTA and invasive Fractional Flow Reserve.
Measured: ICA within 3 months of initial PCD-CCTA
Correlation and agreement of Plaque composition assessment from PCD-CCTA with intracoronary techniques
Correlation and agreement of Plaque composition assessment from PCD-CCTA in comparison to intracoronary techniques such as optical coherence tomography (OCT) in patients who had both tests done.
Measured: ICA within 3 months of initial PCD-CCTA
Correlation of quantitative PCD-CCTA parameters with the results of additional imaging ischemia tests
Correlation of quantitative PCD-CCTA parameters with imaging ischemia tests in patients who had both PCD-CCTA and one of the following tests done: stress echo, stress Single Photon Emission Computed Tomography (SPECT), stress Positron Emission Tomography (PET), and stress MRI.
Measured: Imaging ischemia tests within 3 months of initial PCD-CCTA
Correlation of quantitative PCD-CCTA parameters with the results of additional other imaging tests
Correlation of quantitative PCD-CCTA parameters with imaging tests in patients who had both PCD-CCTA and one of the following tests done: transthoracic echo, transesophageal echo, cardiac MRI.
Measured: Imaging tests within 3 months of initial PCD-CCTA
Patient management
Recommended and actually performed management based on PCD-CCTA
Measured: at baseline, 1-year follow-up, 2-year follow-up and final follow-up up to a max of 5 years
Analysis of occurrence in Major Adverse Cardiac Events in subgroups
Composite outcome: Analysis of occurrence in MACE as a secondary outcome in following subgroups:
CT plaque characteristic groups: high risk versus other plaques versus no plaques; Plaque burden groups: P1 vs. P2 vs. P3 vs. P4 according to the CAD-RADS 2.0 classification; Gender: male versus female; Age: occurrence of MACE in patient a) under 45 years, b) between 45 and 65 years and c) over 65 years; BMI: Patients with BMI a) under 25, b) between 25 and 30 and c) over 30;
Measured: at baseline, 1-year follow-up, 2-year follow-up and final follow-up up to a max of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start30 Jun 2023 (estimated)
- Primary completion30 Jun 2033 (estimated)
- Study completion30 Jun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Medical Center Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tilman Emrich, University Medical Center Mainz
- Investigators
- Tilman Emrich, MD, Principal investigator, University Medical Center Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877768
- Sponsor's protocol ID
- PCD-CT Registry
- Acronym
- EPIPHANY
- Status last verified
- May 2023
- First submitted
- 10 May 2023
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PCD-CT Registry: Evaluation of Photon Counting Detector-CT Based Image Parameters in the Assessment and Quantification of Coronary Artery Disease (EPIPHANY)
- ClinicalTrials.gov ID
- NCT05877768
- Acronym / sponsor ID
- EPIPHANY / PCD-CT Registry
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University Medical Center MainzUniversity, hospital or other
- Study start
- 30 Jun 2023 (estimated)
- Primary completion
- 30 Jun 2033 (estimated)
- Study completion
- 30 Jun 2033 (estimated)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary Artery Disease | – | Diagnostic Test: Photon Counting Detector Coronary Computed Tomography AngiographyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Clinical indication for a coronary computed tomography angiography (CCTA) for the suspicion of coronary artery disease or the progression thereof
- Written informed consent
Key exclusion criteria (1 listed)
- Contraindications preventing the execution of the CCTA (e.g., pregnancy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photon Counting Detector Coronary Computed Tomography AngiographyAlso: Photon-Counting Detector CT (Naeotom Alpha, Siemens Healthineers)Clinically indicated Photon Counting Detector Coronary Computed Tomography Angiography for the suspicion of coronary artery disease or the progression thereof. | Diagnostic test | Coronary Artery Disease |
Primary outcome
Major Adverse Cardiac Events
Time frame: From inclusion to a maximum follow-up of 5 years
Composite endpoint: major adverse cardiovascular event (MACE); defined as at least one of the following: cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke.
43 secondary outcomes
Objective Image Noise of Photon-Counting Detector Coronary Computed Tomography Angiography (PCD-CCTA)
Time frame: during the PCD-CCTA examination
Objective Assessment of Noise-Power Spectra of PCD-CCTA
Time frame: during the PCD-CCTA examination
Subjective Image Noise of PCD-CCTA
Time frame: during the PCD-CCTA examination
Objective Vessel sharpness in PCD-CCTA
Time frame: during the PCD-CCTA examination
Subjective Vessel sharpness in PCD-CCTA
Time frame: during the PCD-CCTA examination
Objective Image Quality in PCD-CCTA
Time frame: during the PCD-CCTA examination
Subjective Image Quality in PCD-CCTA
Time frame: during the PCD-CCTA examination
Influence of BMI on image quality of the PCD-CCTA
Time frame: during the PCD-CCTA examination
Influence of biological sex on image quality of the PCD-CCTA
Time frame: during the PCD-CCTA examination
Influence of monoenergetic energy levels on image quality of the PCD-CCTA
Time frame: during the PCD-CCTA examination
Influence of slice thickness of reconstruction on image quality of the PCD-CCTA
Time frame: during the PCD-CCTA examination
Influence of reconstruction kernel on image quality of the PCD-CCTA
Time frame: during the PCD-CCTA examination
Influence of kernel sharpness level on image quality of the PCD-CCTA
Time frame: during the PCD-CCTA examination
Influence of radiation dose on image quality of the PCD-CCTA
Time frame: during the PCD-CCTA examination
Influence of the patients heart rate on image quality of the PCD-CCTA
Time frame: during the PCD-CCTA examination
Influence of the acquisition type on image quality of the PCD-CCTA
Time frame: during the PCD-CCTA examination
Quantitative analysis of Coronary Calcium Scoring from PCD-CCTA
Time frame: during the PCD-CCTA examination
Analysis of Stenosis Classification from PCD-CCTA
Time frame: during the PCD-CCTA examination
Quantitative analysis of Coronary Diameter Stenoses from PCD-CCTA
Time frame: during the PCD-CCTA examination
Quantitative analysis of Coronary Area Stenoses from PCD-CCTA
Time frame: during the PCD-CCTA examination
Quantitative analysis of computed Fractional Flow Reserve from PCD-CCTA
Time frame: during the PCD-CCTA examination
Quantitative analysis of myocardial density from PCD-CCTA
Time frame: during the PCD-CCTA examination
Quantitative analysis of myocardial iodine content from PCD-CCTA
Time frame: during the PCD-CCTA examination
Quantitative analysis of extracellular volume fraction from PCD-CCTA
Time frame: during the PCD-CCTA examination
Influence of BMI on quantitative parameters of the PCD-CCTA
Time frame: during the PCD-CCTA examination
Influence of biological sex on quantitative parameters of the PCD-CCTA
Time frame: during the PCD-CCTA examination
Influence of monoenergetic energy levels on quantitative parameters of the PCD-CCTA
Time frame: during the PCD-CCTA examination
Influence of slice thickness of reconstruction on quantitative parameters of the PCD-CCTA
Time frame: during the PCD-CCTA examination
Influence of reconstruction kernel on quantitative parameters of the PCD-CCTA
Time frame: during the PCD-CCTA examination
Influence of kernel sharpness level on quantitative parameters of the PCD-CCTA
Time frame: during the PCD-CCTA examination
Influence of radiation dose on quantitative parameters of the PCD-CCTA
Time frame: during the PCD-CCTA examination
Influence of the patients heart rate on quantitative parameters of the PCD-CCTA
Time frame: during the PCD-CCTA examination
Influence of the acquisition type on quantitative parameters of the PCD-CCTA
Time frame: during the PCD-CCTA examination
Rates of patients undergoing further cardiac diagnostics
Time frame: 2 weeks after initial PCD-CCTA, 1-year follow-up, 2-year follow-up and final follow-up up to a max of 5 years
Rates of patients undergoing cardiac interventions
Time frame: 2 weeks after initial PCD-CCTA, 1-year follow-up, 2-year follow-up and final follow-up up to a max of 5 years
Correlation and agreement of quantitative measurements from PCD-CCTA with ICA
Time frame: ICA within 3 months of initial PCD-CCTA
Correlation and agreement of non-invasive Fractional Flow Reserve from PCD-CCTA with invasive Fractional Flow Reserve from ICA
Time frame: ICA within 3 months of initial PCD-CCTA
Correlation and agreement of Percent diameter stenosis measurement from PCD-CCTA with Fractional Flow Reserve from ICA
Time frame: ICA within 3 months of initial PCD-CCTA
Correlation and agreement of Plaque composition assessment from PCD-CCTA with intracoronary techniques
Time frame: ICA within 3 months of initial PCD-CCTA
Correlation of quantitative PCD-CCTA parameters with the results of additional imaging ischemia tests
Time frame: Imaging ischemia tests within 3 months of initial PCD-CCTA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tilman Emrich, MD principal investigator
University Medical Center Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by University Medical Center Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tilman Emrich, MD (+49613117 ext. 7358, Tilman.Emrich@unimedizin-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac Events (time frame: From inclusion to a maximum follow-up of 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.