Registry for patients with suspected coronary artery disease undergoing CT angiography

Computed Tomography Coronary Angiography Prognostic Registry for Coronary Artery Disease - CTCA-PRORECAD

This study is trying to see how helpful a special heart scan is for people suspected of having coronary artery disease in understanding their condition and predicting their health over the next year.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Azienda Ospedaliero-Universitaria di Parma (Academic / other)
• Drugs / interventions: radiation
• Locations: 11 sites (Milan, MI and 10 other locations)
• Trial ID: NCT01384721 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather a large population of patients suspected of having coronary artery disease (CAD) who have undergone Computed Tomography Coronary Angiography (CTCA). The researchers will assess the additional value of CTCA in determining the prevalence of obstructive and non-obstructive disease and in predicting patient prognosis. By analyzing anonymized data from institutional databases, the study will evaluate the reliability of CTCA in defining cardiovascular risk and the burden of disease over a minimum follow-up period of 12 months.

Who should consider this trial

Good fit: Ideal candidates include patients with suspected coronary artery disease who have undergone a calcium score assessment and CTCA.

Not a fit: Patients with renal failure, known reactions to iodinated contrast, a history of myocardial infarction, or previous revascularization procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of coronary artery disease prognosis and improve risk stratification for patients.

How similar studies have performed: Other studies utilizing CTCA for risk stratification in coronary artery disease have shown promising results, indicating that this approach is supported by existing evidence.

Eligibility criteria

Inclusion Criteria:

* 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
* Only patients with suspected Coronary Artery Disease

Exclusion Criteria:

* 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)

Where this trial is running

Milan, MI and 10 other locations

• Policlinico San Donato IRCCS — Milan, Mi, Italy (Recruiting)
• Dibimel, Department of Radiology, University of Palermo — Palermo, PA, Italy (Recruiting)
• Azienda Ospedaliero-Universitaria di Parma — Parma, Pr, Italy (Recruiting)
• Department of Radiology - Area Vasta 1 - ASUR Marche — Urbino, Pu, Italy (Recruiting)
• Cardiothoracovascular Department cardiovascular radiology Unit, University Hospital Bologna — Bologna, Italy (Recruiting)
• AUSL n. 1 Toscana - Ospedale di Carrara — Carrara, Italy (Completed)
• Azienda Ospedaliera Universitaria San Martino — Genova, Italy (Recruiting)
• Sdn Irccs — Naples, Italy (Recruiting)
• San Gennaro Hospital — Naples, Italy (Recruiting)
• University of Rome "Sapienza", Polo Pontino — Rome, Italy (Recruiting)
• Università Sapienza di Roma — Rome, Italy (Recruiting)

Study contacts

• Principal investigator: Filippo Cademartiri, MD, PhD — Azienda Ospedaliero-Universitaria di Parma, Italy
• Study coordinator: Filippo Cademartiri, MD, PhD

Conditions Coronary Artery Disease; Atherosclerosis; Computed Tomography Coronary Angiography; Prevalence Of Disease; Prognosis; Risk Stratification