NCT02490397

Brief Summary

The study tests if intense light could be a potential therapy in humans after myocardial infarction by inducing Per2.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2015

Completed
7 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2015

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2020

Completed
Last Updated

June 7, 2021

Status Verified

June 1, 2021

Enrollment Period

5.5 years

First QC Date

June 24, 2015

Last Update Submit

June 2, 2021

Conditions

Coronary ArteriosclerosisMyocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Change of Period 2 (Per2) protein levels

    Measure of Per2 protein levels related to daylight exposure vs. room light exposure after 2 weeks.

    2 weeks

Study Arms (2)

Exposed to Day light

EXPERIMENTAL

Patients with myocardial infarction (MI): This group will be enrolled on the day of their MI. A blood draw will be performed before any light therapy. The patients will then receive a light box (Square One Wake Up Light NatureBright 10,000 LUX) that they shall use every morning from 8.30-9.00 AM for the next 2 weeks. At the conclusion of the two weeks another blood sample will be drawn.

Other: Day Light

Exposed to Room light

SHAM COMPARATOR

Patients with myocardial infarction (MI): This group will be enrolled on the day of their MI and will only be exposed to room light. They will have blood drawn on the day of enrollment and then at 2 weeks after the MI.

Other: Room Light

Interventions

Day LightOTHER

Patients are exposed to day light for 2 weeks after a heart attack. At the end of 2 weeks they will have blood drawn.

Also known as: Active
Exposed to Day light
Room LightOTHER

Patients will be exposed to only room or natural light for 2 weeks after heart attack. At the end of 2 weeks they will have blood drawn.

Also known as: Control
Exposed to Room light

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with an acute myocardial infarction
  • Healthy volunteers
  • Must speak and understand English

You may not qualify if:

  • Patients with an acute myocardial infarction but are too sick, e.g. severe symptoms, chest pain, generally unstable, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Denver | Anschutz Medical Campus

Denver, Colorado, 80220-3706, United States

Location

Related Publications (3)

  • Brainard J, Gobel M, Scott B, Koeppen M, Eckle T. Health implications of disrupted circadian rhythms and the potential for daylight as therapy. Anesthesiology. 2015 May;122(5):1170-5. doi: 10.1097/ALN.0000000000000596. No abstract available.

    PMID: 25635592BACKGROUND

  • Brainard J, Gobel M, Bartels K, Scott B, Koeppen M, Eckle T. Circadian rhythms in anesthesia and critical care medicine: potential importance of circadian disruptions. Semin Cardiothorac Vasc Anesth. 2015 Mar;19(1):49-60. doi: 10.1177/1089253214553066. Epub 2014 Oct 7.

    PMID: 25294583BACKGROUND

  • Eckle T, Hartmann K, Bonney S, Reithel S, Mittelbronn M, Walker LA, Lowes BD, Han J, Borchers CH, Buttrick PM, Kominsky DJ, Colgan SP, Eltzschig HK. Adora2b-elicited Per2 stabilization promotes a HIF-dependent metabolic switch crucial for myocardial adaptation to ischemia. Nat Med. 2012 Apr 15;18(5):774-82. doi: 10.1038/nm.2728.

    PMID: 22504483BACKGROUND

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial Infarction

Interventions

Exercise

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Tobias Eckel, MD, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2015

First Posted

July 3, 2015

Study Start

July 1, 2015

Primary Completion

December 28, 2020

Study Completion

December 28, 2020

Last Updated

June 7, 2021

Record last verified: 2021-06

Locations

US(1)