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Impact of Daylight on Patients With Acute Myocardial Infarction

Primary Purpose

Coronary Arteriosclerosis, Myocardial Infarction

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Day Light
Room Light
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Arteriosclerosis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • University of Colorado Denver | Anschutz Medical Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Exposed to Day light

Exposed to Room light

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 24, 2015
Last Updated
June 2, 2021
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT02490397
Brief Title
Impact of Daylight on Patients With Acute Myocardial Infarction
Official Title
Impact of Daylight on Period 2 Protein and Glycolytic Enzymes in Human Buccal Mucosa and Blood Samples
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
not enough participants
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 28, 2020 (Actual)
Study Completion Date
December 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study tests if intense light could be a potential therapy in humans after myocardial infarction by inducing Per2.
Detailed Description
Damage to the heart caused by a myocardial infarction (heart attack) occurs most often during the early morning hours (6AM). Thus, the involvement of the circadian system (circa= approximately day) has been suggested. The circadian system in humans or animals is based on the rotation of the earth with day and night phases. When humans (or animals) wake up light shines in their eyes and the body receives a signal that the day starts. For the human body it means that certain proteins (named clock, period etc) are produced. The protein that determines the length of a day (awake and sleep period) is called Period 2 (Per2). Recent data indicated that the Per2 protein in hearts from mice is induced after daylight exposure (daylight with an intensity comparable to a bright day at the beach was used, approx. 10 000 LUX). This more Per2 was able to protect the heart from being damaged by no blood going to the heart (protection from a heart attack). This protection was based on a more efficient use of sugars (carbohydrates). Thereby the heart needs less oxygen. Current data indicate that human Per2 is also induced by light exposure and can be detected in human plasma samples. In this study Per2 transcript and protein levels will be analyzed in patients that just experienced a heart attack with and without intense light (daylight) therapy utilizing blood samples (erythrocytes and leukocytes).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Arteriosclerosis, Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exposed to Day light
Arm Type
Experimental
Arm Description
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.
Arm Title
Exposed to Room light
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Day Light
Other Intervention Name(s)
Active
Intervention Description
Patients are exposed to day light for 2 weeks after a heart attack. At the end of 2 weeks they will have blood drawn.
Intervention Type
Other
Intervention Name(s)
Room Light
Other Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Period 2 (Per2) protein levels
Description
Measure of Per2 protein levels related to daylight exposure vs. room light exposure after 2 weeks.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with an acute myocardial infarction Healthy volunteers Must speak and understand English Exclusion Criteria: Patients with an acute myocardial infarction but are too sick, e.g. severe symptoms, chest pain, generally unstable, etc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Eckel, MD, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver | Anschutz Medical Campus
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220-3706
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25635592
Citation
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.
Results Reference
background
PubMed Identifier
25294583
Citation
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.
Results Reference
background
PubMed Identifier
22504483
Citation
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.
Results Reference
background
Links:
URL
http://www.ucdenver.edu/academics/colleges/medicalschool/departments/Anesthesiology/Research/labfacilities/LiCHTLab/Pages/default.aspx
Description
Research Lab

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Impact of Daylight on Patients With Acute Myocardial Infarction

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