Comparison of Nexfin Pulse Contour Analysis and Cardiac M... | NCT01639313

Studies
Comparison of Nexfin Pulse Contour Analysis and Cardiac Magnetic Resonance Imaging for the Measurement of Cardiac Output

NCT01639313

Sponsor

Universitätsmedizin Mannheim

Status

Completed

Last Update Posted

Jul 12, 2012Estimated

Enrollment

39Actual

Phase

Not provided

Conditions

Cardiac Diseases

Interventions

Not provided

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

Jul 2012

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

Jun 2011

Primary Completion Date

Nov 2011Actual

Completion Date

Nov 2011Actual

First Submitted Date

Jul 9, 2012

First Submission Date that Met QC Criteria

Jul 9, 2012

First Posted Date

Jul 12, 2012Estimated

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 9, 2012

Last Update Posted Date

Jul 12, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Joachim Saur, Principal Investigator, Universitätsmedizin MannheimPrincipal Investigator

Lead Sponsor

Universitätsmedizin MannheimOTHER

Collaborators

Not provided

Description Module

Brief Summary

A growing interest in monitoring cardiac output (CO) non-invasively has emerged, however its determination has been difficult using the standard approaches. The aim of the study is to evaluate the accuracy and precision of pulse contour analysis (PCA) as compared to cardiac magnetic resonance imaging (CMR).

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

Not provided

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

39Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

indication for CMR

Exclusion Criteria:

contraindication for CMR
claustrophobia
no consent obtained

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

Hemodynamically stable patients undergoing CMR

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsmedizin Mannheim		Mannheim		68259	Germany