Spanish Registry on Spontaneous Coronary Artery Dissection | NCT03607981

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2015Actual

Primary Completion Date

Jan 1, 2019Estimated

Completion Date

Jan 1, 2020Estimated

First Submitted Date

Jul 24, 2018

First Submission Date that Met QC Criteria

Jul 24, 2018

First Posted Date

Jul 31, 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

Jul 31, 2018

Last Update Posted Date

Aug 2, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Fernando Alfonso, Head of Cardiology Department, Hospital Universitario de La Princesa, Madrid, Spain, Spanish Society of CardiologyPrincipal Investigator

Lead Sponsor

Spanish Society of CardiologyOTHER

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

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.

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

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Predictors of adverse events	Clinical, angiographic and imaging predictors of adverse events during follow-up	3 years

Secondary Outcomes

Measure	Description	Time Frame
Predictors of recurrences	Predictors of recurrences of SCAD at follow-up	3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Those consecutive patients with a novel diagnosis of Spontaneous Coronary Artery Dissection (SCAD) that, after careful information, accepted to sign the informed consent form.

Exclusion Criteria:

Those patients unable to provide informed consent.

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

Consecutive patients with a novel diagnosis of Spontaneous Coronary Artery Dissection (SCAD) that meet the inclusion/exclusion criteria.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marcos Garcia-Guimaraes, MD	Contact	0034666681608		registronacionaldce@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Complexo Universitario Hospitalario de Santiago	Recruiting	Santiago de Compostela	A Coruña	15006	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36244863	Derived	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.
35410894