CClinicalTrials.gg
Status unknownNCT03607981SR-SCADUpdated Aug 2, 2018

Spanish Registry on Spontaneous Coronary Artery Dissection

An observational study in Spontaneous Coronary Artery Dissection, sponsored by Spanish Society of Cardiology. Status unknown at 37 sites in Spain. Per ClinicalTrials.gov, last updated 2018-08-02.

Sponsored by Spanish Society of Cardiology · Observational

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
300
Sex
All
01

Study summary

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

Read the 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.
02

Conditions studied

  • Spontaneous Coronary Artery Dissection
03

In context

Aortic Dissection

385 studies on the registry are indexed under Aortic Dissection; 117 are open to participants now.

This study's planned enrollment of 300 is above the median of 182 across 179 observational studies indexed under Aortic Dissection.

Browse Aortic Dissection studies →

Lead sponsor

Spanish Society of Cardiology is the lead sponsor of 23 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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.

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

Exclusion Criteria:

  • Those patients unable to provide informed consent.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
300 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Predictors of adverse events

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

    Time frame: 3 years

Secondary outcomes

  1. Predictors of recurrences

    Predictors of recurrences of SCAD at follow-up

    Time frame: 3 years

07

Study locations

37 of 37 sites recruiting
  • Complexo Universitario Hospitalario de Santiago
    Santiago de Compostela, A Coruña 15006, Spain
    Recruiting
  • Hospital Central de Asturias
    Oviedo, Asturias 33006, 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 Universitario de Canarias
    San Cristobal 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
    Sevilla, 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
08

References and documents

Publications

  • 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. PubMed 36244863 ↗
  • 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. PubMed 35410894 ↗
  • 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. PubMed 33878074 ↗
  • 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. PubMed 33620451 ↗
  • 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. PubMed 33617813 ↗
  • 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. PubMed 32418854 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03607981
Lead sponsor
Spanish Society of Cardiology
Responsible party
Fernando Alfonso (Head of Cardiology Department, Hospital Universitario de La Princesa, Madrid, Spain, Spanish Society of Cardiology) — Principal investigator
First posted
Jul 31, 2018
Start date
Jan 1, 2015
Primary completion
Jan 1, 2019 (estimated)
Completion
Jan 1, 2020 (estimated)
Last update
Aug 2, 2018

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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