Spontaneous Coronary Artery DissectionSR-SCADNCT03607981
Spanish Registry on Spontaneous Coronary Artery Dissection
An observational study of Spontaneous Coronary Artery Dissection, run by Spanish Society of Cardiology at 37 sites in Spain.
Trial summary
Multicenter observational prospective registry, Spanish nationwide-based, of consecutive patients diagnosed with Spontaneous Coronary Artery Dissection (SCAD) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spontaneous Coronary Artery Dissection
- How many people
- 300 participants
- Where
- 37 sitesSpain
- Study dates
- 1 Jan 2015to 1 Jan 2020
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive patients with a novel diagnosis of Spontaneous Coronary Artery Dissection (SCAD) that meet the inclusion/exclusion criteria.
Who may be able to join
- Those consecutive patients with a novel diagnosis of Spontaneous Coronary Artery Dissection (SCAD) that, after careful information, accepted to sign the informed consent form.
Who cannot join
- Those patients unable to provide informed consent.
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
Spain37 sites, 37 recruiting
- Recruiting
Complexo Hospitalario Universitario A Coruña
A Coruña
Xacobe Flores Ríos, MD, xacobe.flores.rios@sergas.es
- Recruiting
Complejo Hospitalario Universtario de Albacete
Albacete
Jesús Jiménez-Mazuecos, MD, JesusM.Jimenez@uclm.es
- Recruiting
Hospital General de Alicante
Alicante
José Valencia, MD, jvalenciam@hotmail.com
- Recruiting
Hospital Universitario Infanta Cristina
Badajoz, 06080
Jose Ramón López Minguez, MD, lopez-minguez@hotmail.com
- Recruiting
Hospital Germans Trias i Pujol
Badalona
Omar Abdul Jawad Altisent, MD, uzarasl@yahoo.es
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Marcelo Jiménez Kockar, MD, mjimenezKo@santpau.cat
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
Monica Masotti, MD, MASOTTI@clinic.cat
- Recruiting
Hospital del Mar
Barcelona
Beatriz Vaquerizo, MD, beavaquerizo@yahoo.es
- Recruiting
Hospital Puerta del Mar
Cadiz
Alejandro Gutiérrez, MD, aleklos@hotmail.com
- Recruiting
Hospital General Universitario de Ciudad Real
Ciudad Real
Fernando Lozano Ruiz-Poveda, MD, drlozano68@gmail.com
- Recruiting
Hospital Universitario Reina Sofía
Córdoba
Soledad Ojeda Pineda, MD, soledad.ojeda18@gmail.com
- Recruiting
Hospital Galdakao-Usansolo
Galdakao, Vizcaya, 48960
Jose Ramón Rumoroso, MD, rumo@secardiologia.es
- Recruiting
Hospital de Cabueñes
Gijón
Íñigo Lozano Martínez-Luengas, MD, inigo.lozano@gmail.com
- Recruiting
Hospital Universitario Virgen de las Nieves
Granada, 18014
Rafael Melgares, MD, rafael.melgares.sspa@juntadeandalucia.es
- Recruiting
Hospital Juan Ramón Jiménez
Huelva
Santiago Camacho-Freire, MD, navallana@hotmail.com
- Recruiting
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Gerard Roura Ferrer, MD, groura@bellvitgehospital.cat
- Recruiting
Complejo Asistencial Universitario de León
León, 24071
Armando Pérez de Prado, MD, aperez@secardiologia.es
- Recruiting
Hospital Universitario de La Princesa
Madrid, 28006
Fernando Alfonso Manterola, MD, PhD, falf@hotmail.com
Marcos Garcia Guimaraes, MD, registronacionaldce@gmail.com
- Recruiting
Hospital Ramón y Cajal
Madrid, 28034
Rosana Hernández, MD, rhernandez_antolin@hotmail.com
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Maite Velazquez, MD, maitevel05@gmail.com
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
Raúl Moreno, MD, raulmorenog@hotmail.com
- Recruiting
Hospital Clínico San Carlos
Madrid
Fernando Macaya Ten, MD, fernando.macaya.ten@gmail.com
- Recruiting
Hospital General Universitario Gregorio Marañon
Madrid
Ricardo Sanz Ruiz, MD, rsanzruiz@hotmail.com
- Recruiting
Hospital Universitario de Torrejon
Madrid
Eduardo Alegría Barrero, MD, eduar.alegria@gmail.com
- Recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid
Felipe Navarro del Amo, MD, fnavarroa@fjd.es
- Recruiting
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
Arturo Garcia-Touchard, MD, agtouchard@gmail.com
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga
Víctor Becerra, MD, vmbecerram@gmail.com
- Recruiting
Hospital Central de Asturias
Oviedo, Principality of Asturias, 33006
Cesar Morís, MD, cesarmoris@gmail.com
- Recruiting
Hospital de Salamanca
Salamanca
Ignacio Cruz Gonzalez, MD, cruzgonzalez.ignacio@gmail.com
- Recruiting
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
Francisco Bosa Ojeda, MD, franbosa@ull.edu.es
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Gabriela Veiga, MD, gveigafernandez@gmail.com
- Recruiting
Complexo Universitario Hospitalario de Santiago
Santiago de Compostela, A Coruña, 15006
Belen Cid Alvarez, MD, belcid77@hotmail.com
- Recruiting
Hospital Universitario Virgen Macarena
Seville
Rafael Ruiz Salmeron, MD, rjruizsalmeron@yahoo.es
- Recruiting
Complejo Hospitalario de Toledo
Toledo, 45004
José Moreu, MD, jmoreu@sescam.jccm.es
- Recruiting
Hospital Clínico Universitario de Valencia
Valencia
Juan Sanchís, MD, sanchis_juafor@gva.es
- Recruiting
Hospital Universitario y Politécnico La Fe
Valencia
José Luis Díez Gil, MD, diez_jlu@gva.es
- Recruiting
Hospital Universitario Miguel Servet
Zaragoza
Georgina Fuertes Ferre, MD, georginaff@hotmail.com
About this study
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:
- To analyze predisposing factors, potential triggers and associated pathologies of patients presenting with SCAD.
- To study the clinical and angiographic presentation of these patients.
- To analyze the value of intracoronary diagnostic techniques (OCT, IVUS) and non-invasive imaging techniques in the diagnosis of this pathology.
- 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.
- To analyze its long-term clinical evolution (adverse cardiovascular events, including recurrence of SCAD).
- To identify those factors directly related to prognostic and risk of recurrence.
- Conditions
- Spontaneous Coronary Artery Dissection
- Medical subject headings
- Coronary Artery Dissection, Spontaneous
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictors of adverse events
Clinical, angiographic and imaging predictors of adverse events during follow-up
Measured: 3 years
Secondary outcomes (1)
Predictors of recurrences
Predictors of recurrences of SCAD at follow-up
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start1 Jan 2015
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Spontaneous Coronary Artery DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Spanish Society of Cardiology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Alfonso, Spanish Society of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607981
- Sponsor's protocol ID
- SR-SCAD
- Acronym
- SR-SCAD
- Status last verified
- Jul 2018
- First submitted
- 24 Jul 2018
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 36244863Garcia-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 35410894Alfonso 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 33878074Diez-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 33620451Diez-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 33617813Garcia-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
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spanish Registry on Spontaneous Coronary Artery Dissection
- ClinicalTrials.gov ID
- NCT03607981
- Acronym / sponsor ID
- SR-SCAD / SR-SCAD
- Conditions
- Spontaneous Coronary Artery Dissection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Spanish Society of CardiologyUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To analyze predisposing factors, potential triggers and associated pathologies of patients presenting with SCAD.
- To study the clinical and angiographic presentation of these patients.
- To analyze the value of intracoronary diagnostic techniques (OCT, IVUS) and non-invasive imaging techniques in the diagnosis of this pathology.
- 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.
- To analyze its long-term clinical evolution (adverse cardiovascular events, including recurrence of SCAD).
- To identify those factors directly related to prognostic and risk of recurrence.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients with a novel diagnosis of Spontaneous Coronary Artery Dissection (SCAD) that meet the inclusion/exclusion criteria.
Key inclusion criteria (1 listed)
- Those consecutive patients with a novel diagnosis of Spontaneous Coronary Artery Dissection (SCAD) that, after careful information, accepted to sign the informed consent form.
Key exclusion criteria (1 listed)
- Those patients unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictors of adverse events
Time frame: 3 years
Clinical, angiographic and imaging predictors of adverse events during follow-up
1 secondary outcome
Predictors of recurrences
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Derived from this study: PubMed 36244863Alfonso 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.
- Derived from this study: PubMed 35410894Garcia-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.
- Derived from this study: PubMed 33878074Alfonso 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.
- Derived from this study: PubMed 33620451Diez-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.
- Derived from this study: PubMed 33617813Diez-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.
- Derived from this study: PubMed 32418854Garcia-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.
- Individual participant dataSharing planned: Undecided
Related trials for Spontaneous Coronary Artery Dissection
Recruiting
A Study Of Exercise In Patients With Spontaneous Coronary Artery Dissection And Fibromuscular Dysplasia
Fibromuscular Dysplasia, Spontaneous Coronary Artery Dissection
Not yet recruitingPhase 4
Spontaneous Coronary Artery Dissection - AntipLatelet Therapy Intensity in Guided coNservative Management (SCAD-ALIGN) Trial
SCAD, ACS (Acute Coronary Syndrome)
Enrolling by invitationObservational study
Spontaneous Coronary Artery Dissection (SCAD) Avatar Study
Spontaneous Coronary Artery Dissection
Enrolling by invitation
Norwegian Danish Spontaneous Coronary Artery Dissection Exercise Study
Spontaneous Coronary Artery Dissection, Myocardial Infarction (MI)
RecruitingObservational study
Defining the Basis of Fibromuscular Dysplasia (FMD)
Fibromuscular Dysplasia, Spontaneous Coronary Artery Dissection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spontaneous Coronary Artery Dissection, run by Spanish Society of Cardiology at 37 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcos Garcia-Guimaraes, MD (0034666681608, registronacionaldce@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictors of adverse events (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03607981, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.