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Computed Tomography Coronary Angiography (CTCA) Prognostic Registry for Coronary Artery Disease (PRORECAD)

This study is currently recruiting participants.
Verified January 2017 by Filippo Cademartiri, Azienda Ospedaliero-Universitaria di Parma
Sponsor:
ClinicalTrials.gov Identifier:
NCT01384721
First Posted: June 29, 2011
Last Update Posted: January 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Società Italiana di Radiologia Medica
Information provided by (Responsible Party):
Filippo Cademartiri, Azienda Ospedaliero-Universitaria di Parma
  Purpose
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.

Condition
Coronary Artery Disease Atherosclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Computed Tomography Coronary Angiography Prognostic Registry for Coronary Artery Disease - CTCA-PRORECAD

Resource links provided by NLM:


Further study details as provided by Filippo Cademartiri, Azienda Ospedaliero-Universitaria di Parma:

Primary Outcome Measures:
  • MACE/Major Adverse Cardiovascular Events [ Time Frame: at least 12 months ]
    Cardiac Death, Unstable Angina requiring Hospitalization, Acute Myocardial Infarction

  • Cardiovascular risk shifting [ Time Frame: at time 0 ]
    Prevalence of cardiovascular risk category shifting based on coronary plaque burden


Secondary Outcome Measures:
  • Coronary Revascularizations [ Time Frame: after more than 90 days ]
    Coronary Revascularizations occurred at follow-up after CTCA (i.e. PCI/Percutaneous Coronary Revascularization and CABG/Coronary Artery Bypass Graft)

  • Prevalence of outliers [ Time Frame: at time 0 ]
    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)


Estimated Enrollment: 1000
Study Start Date: September 2010
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study 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
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01384721


Contacts
Contact: Filippo Cademartiri, MD, PhD +393493789026 filippocademartiri@gmail.com
Contact: Erica Maffei, MD +393282260947 ericamaffei@gmail.com

Locations
Italy
Dibimel, Department of Radiology, University of Palermo Recruiting
Palermo, PA, Italy, 90127
Contact: Massimo Midiri, MD         
Principal Investigator: Massimo Midiri, MD         
Azienda Ospedaliero-Universitaria di Parma Recruiting
Parma, PR, Italy, 43100
Contact: Filippo Cademartiri, MD, PhD    +393493789026    filippocademartiri@gmail.com   
Sub-Investigator: Erica Maffei, MD         
Principal Investigator: Filippo Cademartiri, MD, PhD         
Cardiothoracovascular Department cardiovascular radiology Unit, University Hospital Bologna Recruiting
Bologna, Italy
Contact: Rossella Fattori       rossella.fattori@unibo.it   
Principal Investigator: Rossella Fattori, MD         
AUSL n. 1 Toscana - Ospedale di Carrara Completed
Carrara, Italy
Azienda Ospedaliera Universitaria San Martino Active, not recruiting
Genova, Italy
Ospedale Galliera Recruiting
Genova, Italy
Contact: Pietro Spagnolo       p.spagnolo@email.it   
Principal Investigator: Pietro Spagnolo, MD         
San Gennaro Hospital Recruiting
Naples, Italy
Contact: Carlo Tedeschi, MD       carlo.tedeschi@hotmail.it   
Principal Investigator: Carlo Tedeschi, MD         
University of Rome "Sapienza", Polo Pontino Recruiting
Rome, Italy
Contact: Marco Rengo       marco.rengo@gmail.com   
Principal Investigator: Marco Rengo, MD         
Università Sapienza di Roma Recruiting
Rome, Italy
Contact: Marco Francone, MD       marco.francone@uniroma1.it   
Principal Investigator: Marco Francone, MD         
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria di Parma
Società Italiana di Radiologia Medica
Investigators
Principal Investigator: Filippo Cademartiri, MD, PhD Azienda Ospedaliero-Universitaria di Parma, Italy
  More Information

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Filippo Cademartiri, Associate Professor, Azienda Ospedaliero-Universitaria di Parma
ClinicalTrials.gov Identifier: NCT01384721     History of Changes
Other Study ID Numbers: SIRM-PRORECAD
First Submitted: June 28, 2011
First Posted: June 29, 2011
Last Update Posted: January 24, 2017
Last Verified: January 2017

Keywords provided by Filippo Cademartiri, Azienda Ospedaliero-Universitaria di Parma:
Computed Tomography Coronary Angiography
Coronary Artery Disease
Prevalence Of Disease
Prognosis
Risk Stratification

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Atherosclerosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases