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NCT02280226 Clinical Trial

Evaluating the Influence of Apnea on Cardiac Function Using Cardiac Magnetic Resonance Imaging.

Physiological Changes in Deliberate Apnea Clinical Trial

Official title:
Evaluating the Influence of Apnea on Heart Function With Strain Analysis and Measurement of Fibrosis Derived From T1-mapping Using Cardiac Magnetic Resonance Imaging (MRI).

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02280226
Other study ID # UBonn-MRI-heart-14
Secondary ID
Status Completed
Phase N/A
First received October 29, 2014
Last updated February 5, 2018
Start date April 2014
Est. completion date July 2016

Study information
Verified date February 2018
Source University Hospital, Bonn
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Former studies revealed a distinct pattern of changes in circulation during deliberate apnea. Blood pressure rises significantly often accompanied by bradycardia. Further studies confirmed a massive increase of total vascular resistance as it also happens in shock to maintain perfusion of heart, lung and brain. This study is to determine the exact alterations of the cardiac function during this reaction, show the redistribution of blood volume in apnea and evaluate possible longterm effects on the central nervous system caused by repeated apnea via magnetic resonance imaging.

Recruitment information / eligibility
Status Completed
Enrollment 17
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria:

- Being able to hold breath deliberately at least 4,5 minutes

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

  • Apnea
  • Physiological Changes in Deliberate Apnea

Intervention

Device:
• magnetic resonance imaging (MRI)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Bonn

Outcome
Type Measure Description Time frame Safety issue
Primary Cardiac Function: Duration of Apnea Alteration of cardiac function in subjects undergoing maximum apnea. every minute under apnea (from 0 up to 9 minutes and rest) depending on personal best with a mean of 5 measurements
Primary Mean Blood Flow Measurement Under Apnea Using MRI Blood flow pattern in subjects undergoing maximum apnea. Every minute under apnea (from 0 up to 9 minutes and rest) depending on personal best with a mean of 5 measurements