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RecruitingNCT03398850SCALIBURUpdated Jan 17, 2018

Spontaneous Coronary Artery Dissection anaLysIs of the Brazilian Updated Registry

An observational study in Coronary Artery Dissection, Spontaneous, sponsored by Hospital Israelita Albert Einstein. Recruiting at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2018-01-17.

Sponsored by Hospital Israelita Albert Einstein · Observational

From the registry’s dates

  • Started Jan 2000; still recruiting 26 years 10 months later.

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Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
250
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Coronary Artery Dissection, Spontaneous

Keywords

  • spontaneous coronary artery dissection
  • acute coronary syndrome
  • coronary angiography
  • coronary tomography
03

In context

Coronary Artery Dissection, Spontaneous

28 studies on the registry are indexed under Coronary Artery Dissection, Spontaneous; 18 are open to participants now.

This study's planned enrollment of 250 is below the median of 457 across 18 observational studies indexed under Coronary Artery Dissection, Spontaneous.

Browse Coronary Artery Dissection, Spontaneous studies →

Lead sponsor

Hospital Israelita Albert Einstein is the lead sponsor of 147 studies on the registry; 32 are open to participants now.

Browse Hospital Israelita Albert Einstein studies →

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

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Non-agreement for SCAD diagnosis
  • Coronary dissections due other mechanisms: unstable atherosclerotic plaque or trauma-induced.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
250 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Long-term clinical outcomes in patients presented with spontaneous coronary artery dissection

    All major adverse cardiac events will be collected

    Time frame: 10 years

Secondary outcomes

  1. Multimodality intravascular imaging findings in patients with spontaneous coronary artery dissection.

    Multimodality intravascular imaging will be recorded

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 27383563 ↗
  • Cade 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 25457056 ↗
  • Saw 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 28302643 ↗
  • Saw 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 24227590 ↗
  • Saw 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 23266235 ↗
  • Cade 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 ↗

Individual participant data

Plan to share: Yes — Data from this observational registry will be shared with others researchers and presented at medical conferences.

Supporting information: Study protocol, Informed consent form

Time frame: The first data will be available by 2019

Access criteria: All researchers will be have the data available upon requested

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2000 (actual). Primary completion is estimated for Dec 2027, 335 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 29, 2017
First posted
Jan 16, 2018
StartActual
Jan 1, 2000
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2027
Last update
Jan 17, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03398850
Lead sponsor
Hospital Israelita Albert Einstein
Responsible party
Adriano Caixeta (Professor of Medicine, Hospital Israelita Albert Einstein) — Principal investigator
First posted
Jan 16, 2018
Start date
Jan 1, 2000
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jan 17, 2018

Study contacts

Carolina Pereira, RN
Contact
carolinap@einstein.br
+551121519408
Jamil Cade, MD, PhD
principal investigator · Hospital Israelita Albert Einstein
Adriano Caixeta, MD, PhD
principal investigator · Hospital Israelita Albert Einstein

Oversight

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

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