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

July 31, 2018 updated by: Fernando Alfonso, Spanish Society of Cardiology
Multicenter observational prospective registry, Spanish nationwide-based, of consecutive patients diagnosed with Spontaneous Coronary Artery Dissection (SCAD)

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • A Coruña, Spain
      • Albacete, Spain
        • Recruiting
        • Complejo Hospitalario Universtario de Albacete
        • Contact:
      • Alicante, Spain
      • Badajoz, Spain, 06080
        • Recruiting
        • Hospital Universitario Infanta Cristina
      • Badalona, Spain
        • Recruiting
        • Hospital Germans Trias i Pujol
        • Contact:
      • Barcelona, Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona
        • Contact:
      • Barcelona, Spain, 08025
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Contact:
      • Cadiz, Spain
        • Recruiting
        • Hospital Puerta del Mar
        • Contact:
      • Ciudad Real, Spain
        • Recruiting
        • Hospital General Universitario de Ciudad Real
        • Contact:
      • Córdoba, Spain
      • Gijón, Spain
        • Recruiting
        • Hospital de Cabueñes
        • Contact:
      • Granada, Spain, 18014
        • Recruiting
        • Hospital Universitario Virgen de Las Nieves
      • Huelva, Spain
        • Recruiting
        • Hospital Juan Ramón Jimenez
        • Contact:
      • León, Spain, 24071
        • Recruiting
        • Complejo Asistencial Universitario de León
        • Contact:
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 De Octubre
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
      • Madrid, Spain
        • Recruiting
        • Hospital General Universitario Gregorio Maranon
        • Contact:
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Ramón y Cajal
      • Madrid, Spain, 28006
      • Madrid, Spain
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Fundacion Jimenez Diaz
        • Contact:
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario de Torrejon
        • Contact:
      • Málaga, Spain
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
        • Contact:
      • Salamanca, Spain
      • Sevilla, Spain
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
      • Toledo, Spain, 45004
        • Recruiting
        • Complejo Hospitalario de Toledo
      • Valencia, Spain
        • Recruiting
        • Hospital Universitario Y Politecnico La Fe
        • Contact:
      • Valencia, Spain
        • Recruiting
        • Hospital Clinico Universitario de Valencia
        • Contact:
      • Zaragoza, Spain
        • Recruiting
        • Hospital Universitario Miguel Servet
        • Contact:
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15006
        • Recruiting
        • Complexo Universitario Hospitalario de Santiago
        • Contact:
    • Asturias
      • Oviedo, Asturias, Spain, 33006
    • Barcelona
      • L´Hospitalet de Llobregat, Barcelona, Spain, 08907
    • Cantabria
      • Santander, Cantabria, Spain, 39008
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Recruiting
        • Hospital Universitario Puerta de Hierro
    • Santa Cruz De Tenerife
      • San Cristobal de La Laguna, Santa Cruz De Tenerife, Spain, 38320
        • Recruiting
        • Hospital Universitario de Canarias
        • Contact:
    • Vizcaya
      • Galdakao, Vizcaya, Spain, 48960
        • Recruiting
        • Hospital Galdakao-Usansolo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictors of adverse events
Time Frame: 3 years
Clinical, angiographic and imaging predictors of adverse events during follow-up
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictors of recurrences
Time Frame: 3 years
Predictors of recurrences of SCAD at follow-up
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Society of Cardiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

July 24, 2018

First Submitted That Met QC Criteria

July 24, 2018

First Posted (Actual)

July 31, 2018

Study Record Updates

Last Update Posted (Actual)

August 2, 2018

Last Update Submitted That Met QC Criteria

July 31, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SR-SCAD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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