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Spanish Registry on Spontaneous Coronary Artery Dissection (SR-SCAD)

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: NCT03607981
Recruitment Status : Unknown
Verified July 2018 by Fernando Alfonso, Spanish Society of Cardiology.
Recruitment status was:  Recruiting
First Posted : July 31, 2018
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Fernando Alfonso, Spanish Society of Cardiology

Study Description
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Brief Summary:
Multicenter observational prospective registry, Spanish nationwide-based, of consecutive patients diagnosed with Spontaneous Coronary Artery Dissection (SCAD)

Condition or disease
Spontaneous Coronary Artery Dissection

Detailed Description:

Multicenter prospective registry on patients with diagnosis of Spontaneous Coronary Artery Dissection (SCAD). Spanish nationwide based, the aims of the current registry are:

  1. To analyze predisposing factors, potential triggers and associated pathologies of patients presenting with SCAD.
  2. To study the clinical and angiographic presentation of these patients.
  3. To analyze the value of intracoronary diagnostic techniques (OCT, IVUS) and non-invasive imaging techniques in the diagnosis of this pathology.
  4. To better understand the in-hospital clinical evolution and the response to medical treatment or revascularization in these challenging patients, taking into account the angiographic or intravascular imaging morphological characteristics of SCAD and the treatment applied.
  5. To analyze its long-term clinical evolution (adverse cardiovascular events, including recurrence of SCAD).
  6. To identify those factors directly related to prognostic and risk of recurrence.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Spanish Registry on Spontaneous Coronary Artery Dissection
Actual Study Start Date : January 1, 2015
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Predictors of adverse events [ Time Frame: 3 years ]
    Clinical, angiographic and imaging predictors of adverse events during follow-up


Secondary Outcome Measures :
  1. Predictors of recurrences [ Time Frame: 3 years ]
    Predictors of recurrences of SCAD at follow-up


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients with a novel diagnosis of Spontaneous Coronary Artery Dissection (SCAD) that meet the inclusion/exclusion criteria.
Criteria

Inclusion Criteria:

  • Those consecutive patients with a novel diagnosis of Spontaneous Coronary Artery Dissection (SCAD) that, after careful information, accepted to sign the informed consent form.

Exclusion Criteria:

  • Those patients unable to provide informed consent.
Contacts and Locations
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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): NCT03607981


Contacts
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Contact: Marcos Garcia-Guimaraes, MD 0034666681608 registronacionaldce@gmail.com

Locations
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Sponsors and Collaborators
Spanish Society of Cardiology
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fernando Alfonso, Head of Cardiology Department, Hospital Universitario de La Princesa, Madrid, Spain, Spanish Society of Cardiology
ClinicalTrials.gov Identifier: NCT03607981    
Other Study ID Numbers: SR-SCAD
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aortic Dissection
Coronary Vessel Anomalies
Vascular Diseases
Dissection, Blood Vessel
Aneurysm
Cardiovascular Diseases
 Acute Aortic Syndrome
Aortic Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities