Non Invasive Measurement of Cardiac Index by Impedance Ca... | NCT01607515

Studies
Non Invasive Measurement of Cardiac Index by Impedance Cardiography

NCT01607515

Sponsor

Medical University of Graz

Status

Completed

Last Update Posted

Sep 9, 2015Estimated

Enrollment

89Actual

Phase

Not Applicable

Conditions

Pulmonary Hypertension

Interventions

Impedance cardiography

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

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

Mar 2012

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Apr 13, 2012

First Submission Date that Met QC Criteria

May 29, 2012

First Posted Date

May 30, 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

Sep 7, 2015

Last Update Posted Date

Sep 9, 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

Pulmonary hypertension (PH) is defined as a pulmonary arterial mean pressure (meanPAP) ≥ 25 mmHg in the right heart catheterization.

There are different forms of PH defined in the classification of Dana Point 2008.

PH is diagnosed with right heart catheterization but there are other non invasive methods which can be used for screening like echocardiography, stress echocardiography and cardio pulmonary exercise testing.

For prognosis of PH patients the limitation of the pulmonary circulation is very important. Therefore the cardiac index (CI) is a good parameter for the right ventricular function. The gold standard for CI measures is the thermodilution, an invasive method performed during right heart catheterization.

Detailed Description

In this study the investigators want to evaluate the impedance cardiography (ICG) as a non invasive method for CI measurement. An alternating current of max 400µA and 45 kHz is conducted through the body. The way of the smallest resistance is the blood in the aorta. The impedance changes with the pulsatile blood flow. Out of the Impedance change there can be calculated the CI.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

89Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
suspected PH	Other	Patients who undergo right heart catheterization for PH diagnosis undergo impedance cardiography	Other: Impedance cardiography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Impedance cardiography	Other	noninvasive measure of cardiac index by impedance cardiography.	suspected PH

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of CI measured by ICG and Thermodilution	assessment of the Specificity and sensitivity of ICG for CI measurement	recruitment over 1.5 year (Data collection), followed by data analysis and interpretation (overall 2 yearsfrom start of recruitment)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who have right heart catheterization written informed consent

Exclusion Criteria:

patients who don't have right heart catheterization no written informed consent

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Horst Olschewski, MD	Medical University of Graz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Graz		Graz		8036	Austria

Condition Browse Module

MeSH Terms

ID	Term
D006976	Hypertension, Pulmonary

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided