Impact of Daylight on Patients With Acute Myocardial Infarction

NCT ID: NCT02490397

Last Updated: 2021-06-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2020-12-28

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).

Conditions

Coronary Arteriosclerosis; Myocardial Infarction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Day Light

Intervention Type: OTHER

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

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.

Group Type: SHAM_COMPARATOR

Room Light

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Active; Control

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tobias Eckel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Denver | Anschutz Medical Campus

Denver, Colorado, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 25635592 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25294583 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22504483 (View on PubMed)

Other Identifiers

13-1607

Identifier Type: -

Identifier Source: org_study_id