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

• Sponsor: Norwegian University of Science and Technology (Other)
• Overall Status: Completed
• CT.gov ID: NCT02494947
• Collaborator: St. Olavs Hospital (Other)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 37.9
• Patients Per Site Per Month: 1.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Disease	Behavioral: high intensity interval-based aerobic exercise; Other: Usual care	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Physical Activity and Lipid Content of Coronary Artery Atheromatous Plaques: a Randomised Trial Using Novel Intracoronary Imaging Techniques
• Actual Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: Apr 1, 2019
• Actual Study Completion Date: Apr 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: interval training high intensity interval-based aerobic exercise	Behavioral: high intensity interval-based aerobic exercise; Interval exercises done 3 times weekly during 6 months according to standard procedures at the Department of Circulation and Medical Imaging.; Other: Usual care
Other: controls usual care	Other: Usual care

Outcome Measures

Primary Outcome Measures

1. lipid content of atherosclerotic coronary artery plaques [6 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Olavs Hospital	Trondheim		Norway

Sponsors and Collaborators

• Norwegian University of Science and Technology
• St. Olavs Hospital

Investigators

• Study Director: Rune Wiseth, phd prof, Norwegian University of Science and Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Norwegian University of Science and Technology
• ClinicalTrials.gov Identifier: NCT02494947
• Other Study ID Numbers: 2015/210
• First Posted: Jul 10, 2015
• Last Update Posted: Aug 26, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Norwegian University of Science and Technology: Coronary Angiography; Exercise
• Additional relevant MeSH terms: Coronary Disease; Coronary Artery Disease

Study Results

No Results Posted as of Aug 26, 2019