Vitality Trial - Sampling Examination Data | NCT01830023

Studies
Vitality Trial - Sampling Examination Data

NCT01830023

Sponsor

RWTH Aachen University

Status

Completed

Last Update Posted

Sep 23, 2015Estimated

Enrollment

2,019Actual

Phase

Not provided

Conditions

Cardiac Event

Interventions

cardiac ultrasound examination

Countries

Germany

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

Sep 2015

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

May 2009

Primary Completion Date

Sep 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Apr 9, 2013

First Submission Date that Met QC Criteria

Apr 10, 2013

First Posted Date

Apr 11, 2013Estimated

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

Sep 22, 2015

Last Update Posted Date

Sep 23, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 study´s aim is to collect data of vitality diagnosis. A cardiac ultrasound examination will be done and the data will be compared to the other examinations.

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

2,019Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cardiac ultrasound examination			Device: cardiac ultrasound examination

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cardiac ultrasound examination	Device	cardiac ultrasound examination to examine the vitality	cardiac ultrasound examination

Measure	Description	Time Frame
vitality data		1 day (at time of examination)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

MRI exmination outcome: positive Late Enhancement, proof of infarction scars by contrast agent.

Exclusion Criteria:

no exclusion criteria as patients are asked to participate after evaluating the MRI examination outcome

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who are examined in the department of cardiology, university hospital Aachen

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Cardiology, university hospital		Aacehn	North Rhine Westfalia	52074	Germany

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided