Effect of Selective and Nonselective Cyclooxygenase Enzyme Inhibition on Arterial Blood Pressure and Cerebral Blood Flow With Exposure to Intermittent Hypoxia in Humans

December 2, 2011 updated by: Marc Poulin, University of Calgary
The study has been designed to assess the effect of cyclooxygenase inhibition on blood pressure, cerebral blood flow, ventilation and renal hemodynamics following chronic intermittent hypoxia exposure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will specifically evaluate:

  1. Cardiovascular effect of cyclooxygenase inhibitors on cerebral, vascular, blood pressure and homeostatic responses following chronic intermittent hypoxia exposure.
  2. Ventilatory response of cyclooxygenase inhibitors following chronic intermittent hypoxia exposure
  3. Evaluate the renal hemodynamic effect of chronic intermittent hypoxia exposure and cyclooxygenase inhibition.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • The Laboratory of Human Cerebrovascular Physiology, HMRB 209 & HMRB 230, University of Calgary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male subjects
  • 18 - 45 years of age
  • Informed written consent

Exclusion Criteria:

  • Any history of cardio-respiratory diseases, ongoing medication, smoking, trauma, acute illnesses, collagen vascular diseases, rheumatoid arthritis, osteoarthritis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial Blood Pressure
Time Frame: Six weeks
Blood pressure will be monitored during all three protocols.
Six weeks
Cerebral Blood Flow
Time Frame: Six weeks
The cerebral blood flow will be mesauresed during each testing days of all three protocols.
Six weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventilatory Response
Time Frame: Six weeks.
The ventilatory response will be measured during each testing days of all three protocols.
Six weeks.
Renal Hemodynamics
Time Frame: Six weeks
The renal hemodynamics will be measured during each testing days of all three protocols.
Six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Investigators

  • Principal Investigator: Marc J Poulin, PhD, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

January 18, 2011

First Submitted That Met QC Criteria

January 19, 2011

First Posted (Estimate)

January 20, 2011

Study Record Updates

Last Update Posted (Estimate)

December 5, 2011

Last Update Submitted That Met QC Criteria

December 2, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UC-MMHAP-COX-IH-2010001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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