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
|Condition or disease||Intervention/treatment||Phase|
|Coronary Arteriosclerosis Myocardial Infarction||Other: Day Light Other: Room Light||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
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
|Contact: Tobias Eckel, MD, PhDemail@example.com|
|Contact: Colleen M Bartman, PhDfirstname.lastname@example.org|
|United States, Colorado|
|University of Colorado||Recruiting|
|Denver, Colorado, United States, 80220-3706|
|Contact: Colleen M Bartman, PhD 330-607-6539 email@example.com|
|Principal Investigator:||Tobias Eckel, MD, PhD||University of Colorado, Denver|