NCT02494947

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

August 26, 2019

Status Verified

August 1, 2019

Enrollment Period

3.2 years

First QC Date

July 6, 2015

Last Update Submit

August 21, 2019

Conditions

Keywords

Coronary AngiographyExercise

Outcome Measures

Primary Outcomes (1)

  • lipid content of atherosclerotic coronary artery plaques

    Lipid core burden index (LCBI) measured by intracoronary near-infrared spectroscopy

    6 months

Study Arms (2)

interval training

EXPERIMENTAL

high intensity interval-based aerobic exercise

Behavioral: high intensity interval-based aerobic exerciseOther: Usual care

controls

OTHER

usual care

Other: Usual care

Interventions

Interval exercises done 3 times weekly during 6 months according to standard procedures at the Department of Circulation and Medical Imaging.

interval training
controlsinterval training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Coronary DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesBehavior

Study Officials

  • Rune Wiseth, phd prof

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2015

First Posted

July 10, 2015

Study Start

February 1, 2016

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

August 26, 2019

Record last verified: 2019-08

Locations