Brief Summary

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

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

300

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach

1 country

37 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5 years study duration

Study Start

First participant enrolled

January 1, 2015

Completed

3.6 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2018

Completed

7 days until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed

5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed

Last Updated

August 2, 2018

Status Verified

July 1, 2018

Enrollment Period

4 years

First QC Date

July 24, 2018

Last Update Submit

July 31, 2018

Conditions

Spontaneous Coronary Artery Dissection

Outcome Measures

Primary Outcomes (1)

Predictors of adverse events
Clinical, angiographic and imaging predictors of adverse events during follow-up
3 years

Secondary Outcomes (1)

Predictors of recurrences
3 years

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Consecutive patients with a novel diagnosis of Spontaneous Coronary Artery Dissection (SCAD) that meet the inclusion/exclusion criteria.

You may qualify if:

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

You may not qualify if:

Those patients unable to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Spanish Society of Cardiologylead

Study Sites (37)

Complexo Universitario Hospitalario de Santiago

Santiago de Compostela, A Coruña, 15006, Spain

RECRUITING

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

RECRUITING

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

RECRUITING

Hospital Central de Asturias

Oviedo, Principality of Asturias, 33006, Spain

RECRUITING

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

RECRUITING

Hospital Galdakao-Usansolo

Galdakao, Vizcaya, 48960, Spain

RECRUITING

Complexo Hospitalario Universitario A Coruña

A Coruña, Spain

RECRUITING

Complejo Hospitalario Universtario de Albacete

Albacete, Spain

RECRUITING

Hospital General de Alicante

Alicante, Spain

RECRUITING

Hospital Universitario Infanta Cristina

Badajoz, 06080, Spain

RECRUITING

Hospital Germans Trias i Pujol

Badalona, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

RECRUITING

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Hospital del Mar

Barcelona, Spain

RECRUITING

Hospital Puerta del Mar

Cadiz, Spain

RECRUITING

Hospital General Universitario de Ciudad Real

Ciudad Real, Spain

RECRUITING

Hospital Universitario Reina Sofía

Córdoba, Spain

RECRUITING

Hospital de Cabueñes

Gijón, Spain

RECRUITING

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

RECRUITING

Hospital Juan Ramón Jiménez

Huelva, Spain

RECRUITING

Complejo Asistencial Universitario de León

León, 24071, Spain

RECRUITING

Hospital Universitario de La Princesa

Madrid, 28006, Spain

RECRUITING

Hospital Ramón y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Hospital Clínico San Carlos

Madrid, Spain

RECRUITING

Hospital General Universitario Gregorio Marañon

Madrid, Spain

RECRUITING

Hospital Universitario de Torrejon

Madrid, Spain

RECRUITING

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, Spain

RECRUITING

Hospital de Salamanca

Salamanca, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, Spain

RECRUITING

Complejo Hospitalario de Toledo

Toledo, 45004, Spain

RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, Spain

RECRUITING

Hospital Universitario y Politécnico La Fe

Valencia, Spain

RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, Spain

RECRUITING

Related Publications (6)

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.
PMID: 36244863DERIVED
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.
PMID: 35410894DERIVED
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.
PMID: 33878074DERIVED
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.
PMID: 33620451DERIVED
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.
PMID: 33617813DERIVED
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.
PMID: 32418854DERIVED

MeSH Terms

Conditions

Coronary Artery Dissection, Spontaneous

Central Study Contacts

Marcos Garcia-Guimaraes, MD

CONTACT

0034666681608 registronacionaldce@gmail.com

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Target Duration: 3 Years
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Head of Cardiology Department, Hospital Universitario de La Princesa, Madrid, Spain

Study Record Dates

First Submitted

July 24, 2018

First Posted

July 31, 2018

Study Start

January 1, 2015

Primary Completion

January 1, 2019

Study Completion

January 1, 2020

Last Updated

August 2, 2018

Record last verified: 2018-07

Locations

ES(37)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (37)

Related Publications (6)

MeSH Terms

Conditions

Central Study Contacts

Study Design

Study Record Dates

Locations