Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT01384721
Recruitment Status : Recruiting
First Posted : June 29, 2011
Last Update Posted : January 13, 2021
Sponsor:
Collaborator:
Società Italiana di Radiologia Medica
Information provided by (Responsible Party):
Filippo Cademartiri, Azienda Ospedaliero-Universitaria di Parma

Brief Summary:
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 or disease
Coronary Artery Disease Atherosclerosis

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Computed Tomography Coronary Angiography Prognostic Registry for Coronary Artery Disease - CTCA-PRORECAD
Study Start Date : September 2010
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2028

Resource links provided by the National Library of Medicine





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

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


Secondary Outcome Measures :
  1. 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)

  2. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

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
Layout table for location contacts
Contact: Filippo Cademartiri, MD, PhD +393493789026 filippocademartiri@gmail.com
Contact: Erica Maffei, MD +393282260947 ericamaffei@gmail.com

Locations
Layout table for location information
Italy
Policlinico San Donato IRCCS Recruiting
Milano, MI, Italy
Contact: Pietro Spagnolo       p.spagnolo@email.it   
Principal Investigator: Pietro Spagnolo, MD         
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         
Department of Radiology - Area Vasta 1 - ASUR Marche Recruiting
Urbino, PU, Italy, 61049
Contact: Erica Maffei, MD    +393282260947    ericamaffei@gmail.com   
Principal Investigator: Erica Maffei, MD         
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 Recruiting
Genova, Italy
Contact: Sara Seitun, MD       saraseitun@yahoo.com   
Principal Investigator: Sara Seitun, MD         
Sdn Irccs Recruiting
Naples, Italy, 80143
Contact: Filippo Cademartiri, MD, PhD    +393441297942    filippocademartiri@gmail.com   
Principal Investigator: Filippo Cademartiri, MD, PhD         
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
Layout table for investigator information
Principal Investigator: Filippo Cademartiri, MD, PhD Azienda Ospedaliero-Universitaria di Parma, Italy
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Filippo Cademartiri, Associate Professor, Azienda Ospedaliero-Universitaria di Parma
ClinicalTrials.gov Identifier: NCT01384721    
Other Study ID Numbers: SIRM-PRORECAD
First Posted: June 29, 2011    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021
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:
Layout table for MeSH terms
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Atherosclerosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases