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Impact of Daylight on Patients With Acute Myocardial Infarction

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ClinicalTrials.gov Identifier: NCT02490397
Recruitment Status : Recruiting
First Posted : July 3, 2015
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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

Condition or disease Intervention/treatment Phase
Coronary Arteriosclerosis Myocardial Infarction Other: Day Light Other: Room Light Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Daylight on Period 2 Protein and Glycolytic Enzymes in Human Buccal Mucosa and Blood Samples
Study Start Date : July 2015
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Exposed to Day light
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
Patients are exposed to day light for 2 weeks after a heart attack. At the end of 2 weeks they will have blood drawn.
Other Name: Active

Sham Comparator: Exposed to Room light
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
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.
Other Name: Control




Primary Outcome Measures :
  1. Change of Period 2 (Per2) protein levels [ Time Frame: 2 weeks ]
    Measure of Per2 protein levels related to daylight exposure vs. room light exposure after 2 weeks.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02490397


Contacts
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Contact: Tobias Eckel, MD, PhD tobias.eckel@ucdenver.edu
Contact: Colleen M Bartman, PhD 330-607-6539 colleen.bartman@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Recruiting
Denver, Colorado, United States, 80220-3706
Contact: Colleen M Bartman, PhD    330-607-6539    colleen.bartman@ucdenver.edu   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Tobias Eckel, MD, PhD University of Colorado, Denver

Additional Information:
Publications:
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02490397     History of Changes
Other Study ID Numbers: 13-1607
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Myocardial Infarction
Coronary Artery Disease
Heart Diseases
Coronary Disease
Arteriosclerosis
Myocardial Ischemia
Infarction
Ischemia
Pathologic Processes
Necrosis
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases