Spontaneous Coronary Artery Dissection anaLysIs of the Brazilian Updated Registry (SCALIBUR)

January 12, 2018 updated by: Adriano Caixeta, Hospital Israelita Albert Einstein

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil
        • Recruiting
        • Hospital Israelita Albert Einstein
        • Contact:
          • Carolina Pereira, RN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Israelita Albert Einstein

Investigators

  • Principal Investigator: Jamil Cade, MD, PhD, Hospital Israelita Albert Einstein
  • Principal Investigator: Adriano Caixeta, MD, PhD, Hospital Israelita Albert Einstein

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2000

Primary Completion (ANTICIPATED)

December 31, 2027

Study Completion (ANTICIPATED)

December 31, 2027

Study Registration Dates

First Submitted

December 29, 2017

First Submitted That Met QC Criteria

January 11, 2018

First Posted (ACTUAL)

January 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 17, 2018

Last Update Submitted That Met QC Criteria

January 12, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCALIBUR Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data from this observational registry will be shared with others researchers and presented at medical conferences.

IPD Sharing Time Frame

The first data will be available by 2019

IPD Sharing Access Criteria

All researchers will be have the data available upon requested

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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