Clinical trial NCT03607981: Spanish Registry on Spontaneous Coronary Artery Dissection
Official title: Spanish Registry on Spontaneous Coronary Artery Dissection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spontaneous Coronary Artery Dissection
Lead sponsor: Spanish Society of Cardiology
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility 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.

Primary outcomes:
measure: Predictors of adverse events
timeFrame: 3 years
Secondary outcomes:
measure: Predictors of recurrences
timeFrame: 3 years
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Complexo Universitario Hospitalario de Santiago
state: A Coruña
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
state: Asturias
city: L´Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: San Cristobal de La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Santa Cruz De Tenerife
city: Galdakao
country: Spain
facility: Hospital Galdakao-Usansolo
state: Vizcaya
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario A Coruña
city: Albacete
country: Spain
facility: Complejo Hospitalario Universtario de Albacete
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Badajoz
country: Spain
facility: Hospital Universitario Infanta Cristina
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Cadiz
country: Spain
facility: Hospital Puerta del Mar
city: Ciudad Real
country: Spain
facility: Hospital General Universitario de Ciudad Real
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Gijón
country: Spain
facility: Hospital de Cabueñes
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Huelva
country: Spain
facility: Hospital Juan Ramón Jiménez
city: León
country: Spain
facility: Complejo Asistencial Universitario de León
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario de Torrejon
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Salamanca
country: Spain
facility: Hospital de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Toledo
country: Spain
facility: Complejo Hospitalario de Toledo
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
References:
citation: Alfonso F, Sanz-Ruiz R, Sabate M, Macaya F, Roura G, Jimenez-Kockar M, Nogales JM, Velazquez M, Veiga G, Camacho-Freire S, Moreu J, Pelaez JAF, Perez-Espejo P, Amat-Santos IJ, Diez-Villanueva P, Bastante T, Del Val D, Rivero F, Garcia-Guimaraes M. Clinical Implications of the "Broken Line" Angiographic Pattern in Patients With Spontaneous Coronary Artery Dissection. Am J Cardiol. 2022 Dec 15;185:1-9. doi: 10.1016/j.amjcard.2022.09.017. Epub 2022 Oct 13.
citation: Garcia-Guimaraes M, Masotti M, Sanz-Ruiz R, Macaya F, Roura G, Nogales JM, Tizon-Marcos H, Velazquez-Martin M, Veiga G, Flores-Rios X, Abdul-Jawad Altisent O, Jimenez-Kockar M, Camacho-Freire S, Moreu J, Ojeda S, Santos-Martinez S, Sanz-Garcia A, Del Val D, Bastante T, Alfonso F; Spanish Registry on SCAD investigators. Clinical outcomes in spontaneous coronary artery dissection. Heart. 2022 Sep 12;108(19):1530-1538. doi: 10.1136/heartjnl-2022-320830.
citation: Alfonso F, Garcia-Guimaraes M, Alvarado T, Sanz-Ruiz R, Roura G, Amat-Santos IJ, Abdul-Jawad Altisent O, Tizon-Marcos H, Flores-Rios X, Masotti M, Perez-de Prado A, Ferre GF, Ruiz-Poveda FL, Valero E, Portero-Portaz JJ, Diez-Villanueva P, Salamanca J, Bastante T, Rivero F. Clinical implications of arterial hypertension in patients with spontaneous coronary artery dissection. Coron Artery Dis. 2022 Mar 1;33(2):75-80. doi: 10.1097/MCA.0000000000001043.
citation: Diez-Villanueva P, Garcia-Guimaraes M, Sanz-Ruiz R, Roura G, Macaya F, Barahona Alvarado JC, Tizon-Marcos H, Flores-Rios X, Masotti M, Lezcano-Pertejo C, Cortes C, Fuertes-Ferre G, Becerra-Munoz VM, Lozano Ruiz-Poveda F, Valero E, Portero-Portaz JJ, Vera A, Salamanca J, Alfonso F. Spontaneous coronary artery dissection in old patients: clinical features, angiographic findings, management and outcome. Eur Heart J Acute Cardiovasc Care. 2021 Oct 27;10(8):926-932. doi: 10.1093/ehjacc/zuaa029.
citation: Diez-Villanueva P, Garcia-Guimaraes MM, Macaya F, Masotti M, Nogales JM, Jimenez-Kockar M, Velazquez M, Lozano I, Moreu J, Avanzas P, Salamanca J, Alfonso F. Spontaneous Coronary Artery Dissection and Menopause. Am J Cardiol. 2021 Jun 1;148:53-59. doi: 10.1016/j.amjcard.2021.02.007. Epub 2021 Feb 20.
citation: Garcia-Guimaraes M, Bastante T, Macaya F, Roura G, Sanz R, Barahona Alvarado JC, Tizon H, Flores-Rios X, Moreu J, Ojeda S, Nogales JM, Veiga G, Masotti M, Camacho-Freire SJ, Jimenez-Valero S, Jimenez-Kockar M, Lozano I, Gonzalez-Ferreiro R, Velazquez M, Avanzas P, Rivero F, Alfonso F. Spontaneous coronary artery dissection in Spain: clinical and angiographic characteristics, management, and in-hospital events. Rev Esp Cardiol (Engl Ed). 2021 Jan;74(1):15-23. doi: 10.1016/j.rec.2020.04.002. Epub 2020 May 14. English, Spanish.