Computed Tomography Coronary Angiography (CTCA) Prognostic Registry for Coronary Artery Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Ospedaliero-Universitaria di Parma
About this trial
The study aims at pooling a large population of patients with suspected coronary artery disease (CAD) who underwent Computed Tomography Coronary Angiography (CTCA) and who were adequately stratified in the first place. Then the investigators will be able to assess the incremental value of CTCA in the stratification of prevalence of disease (non obstructive/obstructive) and prognosis of patients with suspected CAD). The added information to current evidence is how reliable and to what extent CTCA can define the actual burden of disease and cardiovascular risk.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Only patients with also Calcium Score
≥64-slice CT technology (or 16-slice CT technology with >4 year follow-up)
Number of patients of at least 100 with complete clinical file and follow-up
Minimum follow-up of 12 months
Disqualifiers
renal failure (creatinine clearance <60ml/min)
known previous reaction to iodinated contrast medium and pregnancy
history of Myocardial Infarction
previous revascularization (PCI and/or CABG)
Trial population
Patients referred to CT Coronary angiography for suspected obstructive Coronary Artery Disease based on high cardiovascular risk and/or symptoms and/or test abnormalities
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
MACE/Major Adverse Cardiovascular Events
Cardiac Death, Unstable Angina requiring Hospitalization, Acute Myocardial Infarction
Time frame
at least 12 months2
Cardiovascular risk shifting
Prevalence of cardiovascular risk category shifting based on coronary plaque burden
Time frame
at time 0Secondary outcomes
1
Coronary Revascularizations
Coronary Revascularizations occurred at follow-up after CTCA (i.e. PCI/Percutaneous Coronary Revascularization and CABG/Coronary Artery Bypass Graft)
Time frame
after more than 90 days2
Prevalence of outliers
Prevalence patients lying completely outside the conventional risk stratification (pts with \>3 risk factors and no CAD at CTCA and pts with no risk factors and \>5 coronary segments with CAD)
Time frame
at time 0Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Azienda Ospedaliero-Universitaria di Parma
Lead sponsor
Società Italiana di Radiologia Medica
Collaborator
Source ClinicalTrials.gov