Relationship Between CMR-derived Parameters of Ischemia /... | NCT03522116

Studies
Relationship Between CMR-derived Parameters of Ischemia / Reperfusion Injury and Timing of CMR in STEMI

NCT03522116

Sponsor

Centre Hospitalier Universitaire Vaudois

Status

Completed

Last Update Posted

May 11, 2018Actual

Enrollment

220Actual

Phase

Not provided

Conditions

Myocardial Infarction

Interventions

No intervention

Countries

Not provided

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

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2014Actual

Primary Completion Date

Aug 1, 2016Actual

Completion Date

Jun 30, 2017Actual

First Submitted Date

Apr 30, 2018

First Submission Date that Met QC Criteria

Apr 30, 2018

First Posted Date

May 11, 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

Apr 30, 2018

Last Update Posted Date

May 11, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pier Giorgio Masci, MD, PhD, Centre Hospitalier Universitaire VaudoisPrincipal Investigator

Lead Sponsor

Centre Hospitalier Universitaire VaudoisOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

This a prospective observational study including patients with ST-segment elevation myocardial infarction undergoing cardiovascular magnetic resonance for clinical reason during the index hospitalization. This local registry stemmed from multi-center european registry on cardiovascular magnetic resonance

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

220Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No intervention			Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention	No intervention

Measure	Description	Time Frame
Metrics of ischemia / repercussion injury		June 2017

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of STEMI
Undergoing CMR during the index hospitalization

Exclusion Criteria:

Refractory cardiogenic shock
claustrophobia
eGFR<30 ml/min/1.73m2

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Consecutive patients admitted to Lausanne University Hospital with the diagnosis of STEMI

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009203	Myocardial Infarction

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided