Coronary Artery DiseasePREDICT-CTNCT04827316
Clinical Utility and Outcome Prediction of Cardiovascular Computed Tomography (PREDICT-CT)
An observational study of Coronary Artery Disease and Coronary Arteriosclerosis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
In this study the investigators retrospectively and prospectively collect information from enrolled subjects undergoing CCTA and evaluate the association of cardiac and non-cardiac imaging with laboratory markers and clinical data including outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Arteriosclerosis, Coronary; Ischemic
- How many people
- 4,200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2017to 1 Feb 2031
- How long will I take part?
- 10 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 registry foreseen a prospective cohort composed by patients undergoing clinically indicated CCTA and by a retrospective population of patients that have undergone CCTA 1st June 2017 to 31st December 2020. The principal investigator confirms that no patient's personal health data will be collected if a written or documented oral refusal exist.
Who may be able to join
- Adult individual >18 years
- Undergoing clinically indicated CCTA
- Signed informed consent or waiver
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Cardiology, University Hospital Bern, Inselspital, Bern
Bern, 3010
Christoph Gräni, Prof, +41316324508, christoph.graeni@insel.ch
About this study
In this study the investigators retrospectively and prospectively collect information from enrolled subjects undergoing CCTA and evaluate the association of cardiac and non-cardiac imaging with laboratory markers and clinical data including outcome.
Read the detailed description
In this study the investigators retrospectively and prospectively collect information from enrolled subjects through a period of a total of 10 years to evaluate multidimensional associations between phenotypic manifestations of cardiovascular disease via CCTA and cardiac and non-cardiac imaging, serum biomarkers, demographic and clinical information, clinical presentation (cross-sectional), therapy changes (time-varying) and their ability to predict mortality and MACE (major adverse cardiac event ) (longitudinal) in patients clinically indicated for CCTA.
The aim is to establish a comprehensive cross-sectional, time-varying and longitudinal data collection for individuals undergoing clinically-indicated CCTA to date in order to apply novel multiparametric approaches to determine cardiovascular significance to clinically-important patient-centered events. For data collection this registry will follow a standard CRF (case report form) structure, so to enable the merging of this data-set with other international registries, which might contribute in overcoming some gaps of knowledge from previous CCTA studies.
- Keywords
- Cardiovascular Computed Tomography
- Medical subject headings
- Coronary Artery Disease, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing clinically indicated CCTA | Patients undergoing clinically indicated CCTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause death.
The primary endpoint is the time to first occurrence of death from all-causes.
Measured: 10 years
Secondary outcomes (2)
Major adverse cardiovascular events (MACE)
The secondary composite endpoint is major adverse cardiac events (MACE), which is defined by the occurrence of any of the following events:
- All-cause death
- Myocardial infarction
- Unstable angina-related hospitalization
- Late coronary revascularization (≥90 days)
Measured: 10 years
Other outcome
Occurrence of any of the following events:
- Cerebrovascular accident
- Valvular intervention
- Congestive heart failure-related hospitalization
- Cardiac death
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Jun 2017
- Primary completion1 Feb 2031 (estimated)
- Study completion1 Feb 2031 (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.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- 4,200 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Zürich
- Responsible party
- Sponsor
- Investigators
- Christoph Gräni, MD, PhD, Principal investigator, Department of Cardiology, University Hospital Bern,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827316
- Sponsor's protocol ID
- 2021-00058
- Acronym
- PREDICT-CT
- Status last verified
- Oct 2026
- First submitted
- 29 Mar 2021
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility and Outcome Prediction of Cardiovascular Computed Tomography (PREDICT-CT)
- ClinicalTrials.gov ID
- NCT04827316
- Acronym / sponsor ID
- PREDICT-CT / 2021-00058
- Keywords
- Cardiovascular Computed Tomography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,200 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University Hospital, Zürich
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Feb 2031 (estimated)
- Study completion
- 1 Feb 2031 (estimated)
- First posted
- 1 Apr 2021 (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.
In this study the investigators retrospectively and prospectively collect information from enrolled subjects undergoing CCTA and evaluate the association of cardiac and non-cardiac imaging with laboratory markers and clinical data including outcome.
Detailed description
In this study the investigators retrospectively and prospectively collect information from enrolled subjects through a period of a total of 10 years to evaluate multidimensional associations between phenotypic manifestations of cardiovascular disease via CCTA and cardiac and non-cardiac imaging, serum biomarkers, demographic and clinical information, clinical presentation (cross-sectional), therapy changes (time-varying) and their ability to predict mortality and MACE (major adverse cardiac event ) (longitudinal) in patients clinically indicated for CCTA.
The aim is to establish a comprehensive cross-sectional, time-varying and longitudinal data collection for individuals undergoing clinically-indicated CCTA to date in order to apply novel multiparametric approaches to determine cardiovascular significance to clinically-important patient-centered events. For data collection this registry will follow a standard CRF (case report form) structure, so to enable the merging of this data-set with other international registries, which might contribute in overcoming some gaps of knowledge from previous CCTA studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing clinically indicated CCTA | – | –Patients undergoing clinically indicated CCTA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The registry foreseen a prospective cohort composed by patients undergoing clinically indicated CCTA and by a retrospective population of patients that have undergone CCTA 1st June 2017 to 31st December 2020. The principal investigator confirms that no patient's personal health data will be collected if a written or documented oral refusal exist.
Key inclusion criteria (3 listed)
- Adult individual >18 years
- Undergoing clinically indicated CCTA
- Signed informed consent or waiver
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause death.
Time frame: 10 years
The primary endpoint is the time to first occurrence of death from all-causes.
2 secondary outcomes
Major adverse cardiovascular events (MACE)
Time frame: 10 years
Other outcome
Time frame: 10 years
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 4 Nov 2026.
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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.
Christoph Gräni, MD, PhD principal investigator
Department of Cardiology, University Hospital Bern,
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 and Coronary Arteriosclerosis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 3 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. 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 Switzerland. 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 Christoph Gräni, MD, PHD (+41 31 632 4508, christoph.graeni@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause death. (time frame: 10 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 4 Nov 2026.