Association of T1-mapping and LV Strain Analysis by CMR | NCT03405987

Studies
Association of T1-mapping and LV Strain Analysis by CMR

NCT03405987

Sponsor

Medical University of Vienna

Status

Unknown status

Last Update Posted

Mar 16, 2020Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Myocardial Fibrosis

Interventions

Strain analysis by CMR

Countries

Austria

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

Mar 2020

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

Jul 1, 2012Actual

Primary Completion Date

Dec 1, 2020Estimated

Completion Date

Dec 1, 2020Estimated

First Submitted Date

Jan 14, 2018

First Submission Date that Met QC Criteria

Jan 14, 2018

First Posted Date

Jan 23, 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

Mar 12, 2020

Last Update Posted Date

Mar 16, 2020Actual

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

The association of T1-mapping (both native and ECV) and strain analysis of LV and RV by CMR will be assessed. Results from strain analysis will be investigated in terms of their prognostic value.

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

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ECV < median			Diagnostic Test: Strain analysis by CMR
ECV ≥ median			Diagnostic Test: Strain analysis by CMR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Strain analysis by CMR	Diagnostic Test	Strain analysis by CMR will be performed	ECV < median ECV ≥ median

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Association of native LV T1-values and strain analysis	Association of native LV T1-values and strain analysis by CMR	Baseline
Association of ECV and strain analysis	Association of ECV and strain analysis by CMR	Baseline
Association of strain analysis and outcome	Association of strain analysis by CMR and outcome (combination of cardiovascular hospitalization or death)	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

undergoing CMR
willingness to participate

Exclusion Criteria:

<18 years old
pregnancy

Accepts Healthy Volunteers

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

Patients undergoing CMR for whatever reason will be invited to participate. A specific subgroup of patients are heart failure with preserved ejection fraction.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andreas Kammerlander, MD	Contact	014040046140		andreas.kammerlander@meduniwien.ac.at

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna	Recruiting	Vienna		1090	Austria

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