Spontaneous Coronary Artery Dissection anaLysIs of the Br... | NCT03398850

Studies
Spontaneous Coronary Artery Dissection anaLysIs of the Brazilian Updated Registry

NCT03398850

Sponsor

Hospital Israelita Albert Einstein

Status

Recruiting

Last Update Posted

Jan 17, 2018Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Coronary Artery Dissection, Spontaneous

Interventions

Not provided

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2000Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Dec 29, 2017

First Submission Date that Met QC Criteria

Jan 11, 2018

First Posted Date

Jan 16, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2018

Last Update Posted Date

Jan 17, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Adriano Caixeta, Professor of Medicine, Hospital Israelita Albert EinsteinPrincipal Investigator

Lead Sponsor

Hospital Israelita Albert EinsteinOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Long-term clinical outcomes in patients presented with spontaneous coronary artery dissection	All major adverse cardiac events will be collected	10 years

Secondary Outcomes

Measure	Description	Time Frame
Multimodality intravascular imaging findings in patients with spontaneous coronary artery dissection.	Multimodality intravascular imaging will be recorded	10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Carolina Pereira, RN	Contact	+551121519408		carolinap@einstein.br

Overall Officials

Name	Affiliation	Role
Jamil Cade, MD, PhD	Hospital Israelita Albert Einstein	Principal Investigator
Adriano Caixeta, MD, PhD	Hospital Israelita Albert Einstein	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Israelita Albert Einstein	Recruiting	São Paulo	São Paulo		Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27383563	Background	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.
25457056	Background	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.

ID	Term
C565153	Coronary Artery Dissection, Spontaneous
D054058	Acute Coronary Syndrome

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases