- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01474408
Venous Function in Cardiovascular Disease Patients
February 13, 2017 updated by: Norwegian University of Science and Technology
Venous Function in Cardiovascular Disease Patients; The Neglected Part of Circulatory Regulation
The primary aim is to determine the acute effect of two different training interventions on venous plasticity in patients with myocardial infarction (MI), revascularization or coronary artery graft surgery compared to age-matched healthy subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Compare the effect of 4 x 4 minutes at 90 - 95 % of peak heart rate separated with 3 minutes at 70 % of peaks heart rate and moderate continuous exercise at 70 % of peak heart rate on venous function.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
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
-
-
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Trondheim, Norway
- Institutt for Sirkulasjon og Bildetechnikk, NTNU
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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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- myocardial infraction (MI)
- revascularization (PCI)
- coronary artery bypass graft surgery (CABG)
Exclusion Criteria:
- unstable angina pectoris
- uncontrolled hypertension
- orthopedic and/or neurological limitations
- participation in other studies
- MI (closer than 4 weeks)
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: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: interval training
4 x 4 minutes exercise at 90 - 95 % of peak heart rate separated with 3 minutes at 70 % of peaks heart rate
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Other Names:
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Active Comparator: moderate exercise
moderate continuous exercise at 70 % of peak heart rate on venous function.
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Other Names:
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Other: control
routine measurements, no exercise
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Venous Compliance change
Time Frame: 48 hours
|
Measured by echocardiography
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48 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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.
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
November 1, 2011
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
November 4, 2011
First Submitted That Met QC Criteria
November 15, 2011
First Posted (Estimate)
November 18, 2011
Study Record Updates
Last Update Posted (Actual)
February 14, 2017
Last Update Submitted That Met QC Criteria
February 13, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011/760
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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