Coronary Artery Dissection, SpontaneousSCALIBURNCT03398850
Spontaneous Coronary Artery Dissection anaLysIs of the Brazilian Updated Registry
An observational study of Coronary Artery Dissection, Spontaneous, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial summary
A retrospective and prospective registry will evaluate demographic and angiographic data in patients with spontaneous coronary artery dissection (SCAD) using medical records, invasive coronary angiography, intravascular imaging and/or computed multislice coronary tomography. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Dissection, Spontaneous
- How many people
- 250 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2000to 31 Dec 2027
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The present study population will be selected retrospectively and prospectively from several Brazilian tertiary Hospitals. Clinical data and coronary imaging will be imputed through electronic case report form (eCRF), which will be kept confidential at dedicated server at the Coordinator Center, Hospital Israelita Albert Einstein.
Who may be able to join
- Patients with coronary manifestations due spontaneous coronary artery dissection
- Angiographic findings of SCAD in coronary angiogram or coronary tomography
- Agreement between two or more invasive cardiologists (adjudicated committee) for the diagnosis.
Who cannot join
- Non-agreement for SCAD diagnosis
- Coronary dissections due other mechanisms: unstable atherosclerotic plaque or trauma-induced.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Israelita Albert Einstein
São Paulo, São Paulo
Carolina Pereira, RN
About this study
Official title: Spontaneous Coronary Artery Dissection anaLysIs of the Brazilian Updated Registry: Epidemiological Data, Clinical Results and Long-Term Follow-up (SCALIBUR Registry).
A retrospective and prospective registry will evaluate demographic and angiographic data in patients with spontaneous coronary artery dissection (SCAD) using medical records, invasive coronary angiography, intravascular imaging and/or computed multislice coronary tomography. The type of treatment applied during index hospitalization (i.e., clinical management, percutaneous coronary intervention or coronary artery bypass grafting) will be evaluated. Long-term follow-up (up to 10 years) will be also reported.
- Conditions
- Coronary Artery Dissection, Spontaneous
- Keywords
- spontaneous coronary artery dissection, acute coronary syndrome, coronary angiography, coronary tomography
- Medical subject headings
- Coronary Artery Dissection, Spontaneous, Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term clinical outcomes in patients presented with spontaneous coronary artery dissection
All major adverse cardiac events will be collected
Measured: 10 years
Secondary outcomes (1)
Multimodality intravascular imaging findings in patients with spontaneous coronary artery dissection.
Multimodality intravascular imaging will be recorded
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start1 Jan 2000
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (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 Coronary Artery Dissection, SpontaneousStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adriano Caixeta, Hospital Israelita Albert Einstein
- Investigators
- Jamil Cade, MD, PhD, Principal investigator, Hospital Israelita Albert EinsteinAdriano Caixeta, MD, PhD, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398850
- Sponsor's protocol ID
- SCALIBUR Registry
- Acronym
- SCALIBUR
- Status last verified
- Jan 2018
- First submitted
- 29 Dec 2017
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from this observational registry will be shared with others researchers and presented at medical conferences.
Publications
Cade J, Mintz GS, Silva RM Filho, Caixeta A. Spontaneous coronary artery dissection and healing documented by optical coherence tomography. Einstein (Sao Paulo). 2016 Jul-Sep;14(3):435-436. doi: 10.1590/S1679-45082016AI3551. Epub 2016 Jul 4. No abstract available.
PubMed 27383563Cade JR, Abizaid A, Caixeta A. Organized thrombus mimicking spontaneous coronary artery dissection. JACC Cardiovasc Interv. 2014 Dec;7(12):1458. doi: 10.1016/j.jcin.2014.08.004. Epub 2014 Nov 12. No abstract available.
PubMed 25457056Saw J. Pregnancy-Associated Spontaneous Coronary Artery Dissection Represents an Exceptionally High-Risk Spontaneous Coronary Artery Dissection Cohort. Circ Cardiovasc Interv. 2017 Mar;10(3):e005119. doi: 10.1161/CIRCINTERVENTIONS.117.005119. No abstract available.
PubMed 28302643Saw J. Coronary angiogram classification of spontaneous coronary artery dissection. Catheter Cardiovasc Interv. 2014 Dec 1;84(7):1115-22. doi: 10.1002/ccd.25293. Epub 2013 Dec 4.
PubMed 24227590Saw J, Ricci D, Starovoytov A, Fox R, Buller CE. Spontaneous coronary artery dissection: prevalence of predisposing conditions including fibromuscular dysplasia in a tertiary center cohort. JACC Cardiovasc Interv. 2013 Jan;6(1):44-52. doi: 10.1016/j.jcin.2012.08.017. Epub 2012 Dec 19.
PubMed 23266235Cade JR, Szarf G, de Siqueira ME, Chaves A, Andrea JC, Figueira HR, Gomes MM Jr, Freitas BP, Filgueiras Medeiros J, Dos Santos MR, Fiorotto WB, Daige A, Goncalves R, Cantarelli M, Alves CM, Echenique L, de Brito FS Jr, Perin MA, Born D, Hecht H, Caixeta A. Pregnancy-associated spontaneous coronary artery dissection: insights from a case series of 13 patients. Eur Heart J Cardiovasc Imaging. 2017 Jan;18(1):54-61. doi: 10.1093/ehjci/jew021. Epub 2016 Feb 28.
PubMed 26928981
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spontaneous Coronary Artery Dissection anaLysIs of the Brazilian Updated Registry: Epidemiological Data, Clinical Results and Long-Term Follow-up (SCALIBUR Registry).
- ClinicalTrials.gov ID
- NCT03398850
- Acronym / sponsor ID
- SCALIBUR / SCALIBUR Registry
- Conditions
- Coronary Artery Dissection, Spontaneous
- Keywords
- spontaneous coronary artery dissection, acute coronary syndrome, coronary angiography, coronary tomography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Jan 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.
A retrospective and prospective registry will evaluate demographic and angiographic data in patients with spontaneous coronary artery dissection (SCAD) using medical records, invasive coronary angiography, intravascular imaging and/or computed multislice coronary tomography. The type of treatment applied during index hospitalization (i.e., clinical management, percutaneous coronary intervention or coronary artery bypass grafting) will be evaluated. Long-term follow-up (up to 10 years) will be also reported.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The present study population will be selected retrospectively and prospectively from several Brazilian tertiary Hospitals. Clinical data and coronary imaging will be imputed through electronic case report form (eCRF), which will be kept confidential at dedicated server at the Coordinator Center, Hospital Israelita Albert Einstein.
Key inclusion criteria (3 listed)
- Patients with coronary manifestations due spontaneous coronary artery dissection
- Angiographic findings of SCAD in coronary angiogram or coronary tomography
- Agreement between two or more invasive cardiologists (adjudicated committee) for the diagnosis.
Key exclusion criteria (2 listed)
- Non-agreement for SCAD diagnosis
- Coronary dissections due other mechanisms: unstable atherosclerotic plaque or trauma-induced.
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
Long-term clinical outcomes in patients presented with spontaneous coronary artery dissection
Time frame: 10 years
All major adverse cardiac events will be collected
1 secondary outcome
Multimodality intravascular imaging findings in patients with spontaneous coronary artery dissection.
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Background: PubMed 27383563Cade J, Mintz GS, Silva RM Filho, Caixeta A. Spontaneous coronary artery dissection and healing documented by optical coherence tomography. Einstein (Sao Paulo). 2016 Jul-Sep;14(3):435-436. doi: 10.1590/S1679-45082016AI3551. Epub 2016 Jul 4. No abstract available.
- Background: PubMed 25457056Cade JR, Abizaid A, Caixeta A. Organized thrombus mimicking spontaneous coronary artery dissection. JACC Cardiovasc Interv. 2014 Dec;7(12):1458. doi: 10.1016/j.jcin.2014.08.004. Epub 2014 Nov 12. No abstract available.
- Background: PubMed 28302643Saw J. Pregnancy-Associated Spontaneous Coronary Artery Dissection Represents an Exceptionally High-Risk Spontaneous Coronary Artery Dissection Cohort. Circ Cardiovasc Interv. 2017 Mar;10(3):e005119. doi: 10.1161/CIRCINTERVENTIONS.117.005119. No abstract available.
- Background: PubMed 24227590Saw J. Coronary angiogram classification of spontaneous coronary artery dissection. Catheter Cardiovasc Interv. 2014 Dec 1;84(7):1115-22. doi: 10.1002/ccd.25293. Epub 2013 Dec 4.
- Background: PubMed 23266235Saw J, Ricci D, Starovoytov A, Fox R, Buller CE. Spontaneous coronary artery dissection: prevalence of predisposing conditions including fibromuscular dysplasia in a tertiary center cohort. JACC Cardiovasc Interv. 2013 Jan;6(1):44-52. doi: 10.1016/j.jcin.2012.08.017. Epub 2012 Dec 19.
- Results publication: PubMed 26928981Cade JR, Szarf G, de Siqueira ME, Chaves A, Andrea JC, Figueira HR, Gomes MM Jr, Freitas BP, Filgueiras Medeiros J, Dos Santos MR, Fiorotto WB, Daige A, Goncalves R, Cantarelli M, Alves CM, Echenique L, de Brito FS Jr, Perin MA, Born D, Hecht H, Caixeta A. Pregnancy-associated spontaneous coronary artery dissection: insights from a case series of 13 patients. Eur Heart J Cardiovasc Imaging. 2017 Jan;18(1):54-61. doi: 10.1093/ehjci/jew021. Epub 2016 Feb 28.
- Individual participant dataSharing planned: Yes. Data from this observational registry will be shared with others researchers and presented at medical conferences.
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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.
Jamil Cade, MD, PhD principal investigator
Hospital Israelita Albert Einstein
Adriano Caixeta, MD, PhD principal investigator
Hospital Israelita Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Dissection, Spontaneous, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carolina Pereira, RN (+551121519408, carolinap@einstein.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term clinical outcomes in patients presented with spontaneous coronary artery dissection (time frame: 10 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 NCT03398850, 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 17 Jan 2018.