Spanish Registry on Spontaneous Coronary Artery Dissection

Spontaneous Coronary Artery Dissection Clinical Trial

— SR-SCAD  

Official title:

Spanish Registry on Spontaneous Coronary Artery Dissection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03607981
• Other study ID #: SR-SCAD
• Status: Recruiting
• Start date: January 1, 2015
• Est. completion date: January 1, 2020

Study information

• Verified date: July 2018
• Source: Spanish Society of Cardiology
• Contact: Marcos Garcia-Guimaraes, MD
• Phone: 0034666681608
• Email: registronacionaldce[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Spontaneous Coronary Artery Dissection

Locations

Country	Name	City	State
Spain	Complexo Hospitalario Universitario A Coruña	A Coruña
Spain	Complejo Hospitalario Universtario de Albacete	Albacete
Spain	Hospital General de Alicante	Alicante
Spain	Hospital Universitario Infanta Cristina	Badajoz
Spain	Hospital Germans Trias i Pujol	Badalona
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Puerta del Mar	Cadiz
Spain	Hospital General Universitario de Ciudad Real	Ciudad Real
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital Galdakao-Usansolo	Galdakao	Vizcaya
Spain	Hospital de Cabueñes	Gijón
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital Juan Ramón Jiménez	Huelva
Spain	Hospital Universitari de Bellvitge	L´Hospitalet de Llobregat	Barcelona
Spain	Complejo Asistencial Universitario de León	León
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario de Torrejon	Madrid
Spain	Hospital Universitario Fundación Jiménez Díaz	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital Universitario Virgen de la Victoria	Málaga
Spain	Hospital Central de Asturias	Oviedo	Asturias
Spain	Hospital de Salamanca	Salamanca
Spain	Hospital Universitario de Canarias	San Cristobal de La Laguna	Santa Cruz De Tenerife
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Complexo Universitario Hospitalario de Santiago	Santiago de Compostela	A Coruña
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Complejo Hospitalario de Toledo	Toledo
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital Universitario y Politécnico La Fe	Valencia
Spain	Hospital Universitario Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Spanish Society of Cardiology

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictors of adverse events	Clinical, angiographic and imaging predictors of adverse events during follow-up	3 years
Secondary	Predictors of recurrences	Predictors of recurrences of SCAD at follow-up	3 years