Coronary StenosisCCT-PCD-1NCT05551351
CT in Calcified Coronary Arteries With Photon Counting Detector
An observational study of Coronary Stenosis and Calcific Coronary Arteriosclerosis, run by Region Örebro County at 1 site in Sweden.
Trial summary
Coronary CT angiography is challenging in patients with more than mildly calcified coronary vessels, because of calcium artefacts that prevents evaluation of the lumen. The purpose of the CCT-PCD-1-study is to evaluate the diagnostic accuracy and image quality in coronary CT angiography using a commercially available… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Coronary Stenosis, Calcific Coronary Arteriosclerosis
- What is being tested?
- Cardiac CT with photon counting detector
- How many people
- 29 participants
- Where
- 1 siteSweden
- Study dates
- 16 Feb 2023to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The study population are at least 65 years old with an expected median age of ~80 years. This group of patients has generally a high coronary artery calcium burden which prevents conventional cardiac CT from evaluation of the coronary arteries. Since cardiac CT and coronary artery angiography is performed as part of routine care in this patient cohort, no extra examinations are needed for the reference measure of the primary outcome.
Who may be able to join
- Patients referred for cardiac CT AND conventional coronary angiography as part of routine preoperative evaluation.
Who cannot join
- <65 years old.
- Heart arrhythmia.
- Heart rate >90/min with contraindication against beta blockers.
- Not capable of giving informed consent
- eGFR <30 mL/min/1.73m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CT av förkalkade kranskärl Med fotonräknarteknik
Coronary CT angiography is challenging in patients with more than mildly calcified coronary vessels, because of calcium artefacts that prevents evaluation of the lumen. The purpose of the CCT-PCD-1-study is to evaluate the diagnostic accuracy and image quality in coronary CT angiography using a commercially available CT system equipped with a photon counting detector technology.
Patients referred for cardiac CT and conventional coronary angiography as part of routine preoperative evaluation before Transcatheter Aortic Valve Implantation (TAVI) will be asked for inclusion in the study. This group of patients has generally a coronary artery calcium burden and perform cardiac CT and coronary angiography as part of routine care.
The diagnostic accuracy concerning significant coronary artery stenosis on the preoperative CT will be evaluated with the conventional coronary angiography as reference. Also, CT examination image quality will be evaluated.
- Being tested
- Cardiac CT with photon counting detector
- Keywords
- Cardiac Computed Tomography, Photon Counting Detector
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac CT with photon counting detectorDiagnostic test
Cardiac CT including the coronary arteries. The cardiac CT is performed in routine care for the included patients.
| Study group | Role | What they receive |
|---|---|---|
| Coronary CT | The single cohort consists of all patients enrolled in the study. All participants performs cardiac CT and coronary angiography as part of routine care. Receives: Diagnostic Test: Cardiac CT with photon counting detector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of CT concerning coronary stenosis with conventional angiography as reference
Coronary angiography with or without FFR is performed as part of routine care for included patients. The outcome measure is the agreement between coronary CT and coronary angiography.
Measured: 1 day. (Coronary angiography is usually performed the same day as cardiac CT.)
Secondary outcomes (1)
Image quality
Image quality on CT examination according to European guidelines on quality criteria for computed tomography
Measured: 1 day. (Image quality is assessed on the performed examination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start16 Feb 2023
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Why it stopped: Enrollment rate too slow to reach anticipated number of participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary StenosisStudies 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mats Lidén, MD, PhD, Principal investigator, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551351
- Sponsor's protocol ID
- 278326
- Acronym
- CCT-PCD-1
- Status last verified
- Apr 2025
- First submitted
- 13 Sep 2022
- Last updated
- 16 Apr 2025
- 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 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT av förkalkade kranskärl Med fotonräknarteknik
- ClinicalTrials.gov ID
- NCT05551351
- Acronym / sponsor ID
- CCT-PCD-1 / 278326
- Keywords
- Cardiac Computed Tomography, Photon Counting Detector
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Enrollment rate too slow to reach anticipated number of participants.
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 22 Sep 2022 (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.
Coronary CT angiography is challenging in patients with more than mildly calcified coronary vessels, because of calcium artefacts that prevents evaluation of the lumen. The purpose of the CCT-PCD-1-study is to evaluate the diagnostic accuracy and image quality in coronary CT angiography using a commercially available CT system equipped with a photon counting detector technology.
Patients referred for cardiac CT and conventional coronary angiography as part of routine preoperative evaluation before Transcatheter Aortic Valve Implantation (TAVI) will be asked for inclusion in the study. This group of patients has generally a coronary artery calcium burden and perform cardiac CT and coronary angiography as part of routine care.
The diagnostic accuracy concerning significant coronary artery stenosis on the preoperative CT will be evaluated with the conventional coronary angiography as reference. Also, CT examination image quality will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary CT | – | Diagnostic Test: Cardiac CT with photon counting detectorThe single cohort consists of all patients enrolled in the study. All participants performs cardiac CT and coronary angiography as part of routine care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population are at least 65 years old with an expected median age of ~80 years. This group of patients has generally a high coronary artery calcium burden which prevents conventional cardiac CT from evaluation of the coronary arteries. Since cardiac CT and coronary artery angiography is performed as part of routine care in this patient cohort, no extra examinations are needed for the reference measure of the primary outcome.
Key inclusion criteria (1 listed)
- Patients referred for cardiac CT AND conventional coronary angiography as part of routine preoperative evaluation.
Key exclusion criteria (5 listed)
- <65 years old.
- Heart arrhythmia.
- Heart rate >90/min with contraindication against beta blockers.
- Not capable of giving informed consent
- eGFR <30 mL/min/1.73m2
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 |
|---|---|---|
| Cardiac CT with photon counting detectorCardiac CT including the coronary arteries. The cardiac CT is performed in routine care for the included patients. | Diagnostic test | Coronary CT |
Primary outcome
Diagnostic accuracy of CT concerning coronary stenosis with conventional angiography as reference
Time frame: 1 day. (Coronary angiography is usually performed the same day as cardiac CT.)
Coronary angiography with or without FFR is performed as part of routine care for included patients. The outcome measure is the agreement between coronary CT and coronary angiography.
1 secondary outcome
Image quality
Time frame: 1 day. (Image quality is assessed on the performed examination)
Results and safety
The study was stopped early (reason given: Enrollment rate too slow to reach anticipated number of participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
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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. This study is not recruiting at the moment.
Mats Lidén, MD, PhD principal investigator
Örebro University, Sweden
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 Stenosis and Calcific Coronary Arteriosclerosis, run by Region Örebro County at 1 site in Sweden.
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 1 inclusion and 5 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: stopped early, as of the sponsor's last update on 16 Apr 2025. 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 Sweden. 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?
The study was stopped early (reason given: Enrollment rate too slow to reach anticipated number of participants.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of CT concerning coronary stenosis with conventional angiography as reference (time frame: 1 day. (Coronary angiography is usually performed the same day as cardiac CT.)). 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 16 Apr 2025.