Not provided
Not provided
Not provided
Not provided
Not provided
Enrollment rate too slow to reach anticipated number of participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac CT with photon counting detector | Diagnostic Test | Cardiac CT including the coronary arteries. The cardiac CT is performed in routine care for the included patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day. (Coronary angiography is usually performed the same day as cardiac CT.) |
| Measure | Description | Time Frame |
|---|---|---|
| Image quality | Image quality on CT examination according to European guidelines on quality criteria for computed tomography | 1 day. (Image quality is assessed on the performed examination) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mats Lidén, MD, PhD | Örebro University, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Röntgenkliniken Universitetssjukhuset Örebro | Örebro | Sweden |
Not provided
| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| D014652 |
| Vascular Diseases |