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Coronary Disease and the Effect of High-intensity Interval Training (CENIT)

Primary Purpose

Coronary Disease

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
high intensity interval-based aerobic exercise
Usual care
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring Coronary Angiography, Exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • stable coronary artery disease
  • will undergo cardiac catheterization
  • will be treated with percutaneous coronary intervention (PCI)
  • signed written informed consent
  • able to execute the intervention

Exclusion Criteria:

  • earlier bypass surgery
  • known inflammatory disease other than atherosclerosis
  • planned surgery within 4 months
  • included in another randomized controlled study

Sites / Locations

  • St Olavs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

interval training

controls

Arm Description

high intensity interval-based aerobic exercise

usual care

Outcomes

Primary Outcome Measures

lipid content of atherosclerotic coronary artery plaques
Lipid core burden index (LCBI) measured by intracoronary near-infrared spectroscopy

Secondary Outcome Measures

Full Information

First Posted
July 6, 2015
Last Updated
August 21, 2019
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02494947
Brief Title
Coronary Disease and the Effect of High-intensity Interval Training
Acronym
CENIT
Official Title
Physical Activity and Lipid Content of Coronary Artery Atheromatous Plaques: a Randomised Trial Using Novel Intracoronary Imaging Techniques
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary purpose of this study is to investigate if systematic, high intensity, interval-based aerobic exercise training results in regression of lipid content of atherosclerotic coronary artery plaques, and in reduction of plaque burden in patients with stable coronary heart disease. Composition and morphologic characteristics of plaques will be studied by intra-coronary near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS) in patients undergoing percutaneous coronary intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
Keywords
Coronary Angiography, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
interval training
Arm Type
Experimental
Arm Description
high intensity interval-based aerobic exercise
Arm Title
controls
Arm Type
Other
Arm Description
usual care
Intervention Type
Behavioral
Intervention Name(s)
high intensity interval-based aerobic exercise
Intervention Description
Interval exercises done 3 times weekly during 6 months according to standard procedures at the Department of Circulation and Medical Imaging.
Intervention Type
Other
Intervention Name(s)
Usual care
Primary Outcome Measure Information:
Title
lipid content of atherosclerotic coronary artery plaques
Description
Lipid core burden index (LCBI) measured by intracoronary near-infrared spectroscopy
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: stable coronary artery disease will undergo cardiac catheterization will be treated with percutaneous coronary intervention (PCI) signed written informed consent able to execute the intervention Exclusion Criteria: earlier bypass surgery known inflammatory disease other than atherosclerosis planned surgery within 4 months included in another randomized controlled study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rune Wiseth, phd prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35574968
Citation
Vesterbekkmo EK, Madssen E, Aamot Aksetoy IL, Follestad T, Nilsen HO, Hegbom K, Wisloff U, Wiseth R. CENIT (Impact of Cardiac Exercise Training on Lipid Content in Coronary Atheromatous Plaques Evaluated by Near-Infrared Spectroscopy): A Randomized Trial. J Am Heart Assoc. 2022 May 17;11(10):e024705. doi: 10.1161/JAHA.121.024705. Epub 2022 May 16.
Results Reference
derived

Learn more about this trial

Coronary Disease and the Effect of High-intensity Interval Training

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