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Portuguese Registry on Interventional Cardiology (PRIC)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01867801
Recruitment Status : Unknown
Verified June 2017 by Portuguese Society of Cardiology.
Recruitment status was:  Recruiting
First Posted : June 4, 2013
Last Update Posted : June 9, 2017
Sponsor:
Collaborator:
Portuguese Association of Interventional Cardiology
Information provided by (Responsible Party):
Portuguese Society of Cardiology

Brief Summary:
The purpose of this Registry is creating a database management that allows continuous monitoring characteristics, evolution, prognostic indicators and management of patients undergoing coronary angioplasty in Portuguese Hospitals, and identify the appropriateness of clinical and interventional practice recommendations for diagnosis and treatment of coronary disease and monitoring its evolution.

Condition or disease
Coronary Artery Disease

Detailed Description:

Cardiovascular disease remains the main cause of death in Portugal and approximately one quarter of these are directly to ischemic heart disease. In order to better characterize percutaneous coronary intervention in Portugal, the Portuguese Society of Cardiology has promoted the Portuguese registry on percutaneous coronary intervention.

This will include all adult patients (≥ 18 years), eligible for percutaneous coronary intervention (PCI) in accordance with PCI state-of-art recommendations (including unstable and stable coronary disease). The Cardiology department where the patient has been hospitalized is responsible for the patient inclusion in the study.

Excluded patients are those in whom the preferred treatment is Coronary Artery Bypass Graft (CABG), age under 18 years or life expectancy of less than 12 months.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Portuguese Registry on Interventional Cardiology
Study Start Date : January 2002
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Major adverse cardiac event rate (MACE) MACE: A composite of all cause death, documented Myocardial Infarction (MI), unplanned hospitalization leading to urgent revascularization. [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Total mortality [ Time Frame: 12 month ]
    Total mortality at 12 month



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All adult patients admitted to Portuguese hospitals for percutaneous coronary intervention
Criteria

Inclusion Criteria:

  1. Patients with:

    • stable angina or,
    • stabilized angina pectoris or,
    • atypical chest pain or,
    • no chest pain but with documented silent ischemia
  2. At least one stenosis is present of at least 50% in one major native epicardial coronary artery and supplying viable myocardium
  3. Eligible for PCI
  4. Informed consent

Exclusion Criteria:

  1. Patients in whom the preferred treatment is CABG;
  2. Contra-indication to dual antiplatelet therapy
  3. Coronary artery disease precluding PCI
  4. A life expectancy of less than 1 year
  5. Age under 21

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): NCT01867801


Contacts
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Contact: Sandra M Corker 00351 239 838 101 sandra.corker@spc.pt

Locations
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Portugal
CNCDC Recruiting
Coimbra, Portugal, 3000-306
Contact: Sandra M Corker    00351 239 838 101    sandra.corker@spc.pt   
Sponsors and Collaborators
Portuguese Society of Cardiology
Portuguese Association of Interventional Cardiology
Investigators
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Principal Investigator: Marco Costa, MD Portuguese Society of Cardiology
Additional Information:
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Responsible Party: Portuguese Society of Cardiology
ClinicalTrials.gov Identifier: NCT01867801    
Other Study ID Numbers: RNCI
First Posted: June 4, 2013    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: June 2017
Keywords provided by Portuguese Society of Cardiology:
PCI
Coronary disease
Ischemia
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases