Impact of Daylight on Patients With Acute Myocardial Infarction

June 2, 2021 updated by: University of Colorado, Denver

Impact of Daylight on Period 2 Protein and Glycolytic Enzymes in Human Buccal Mucosa and Blood Samples

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80220-3706
        • University of Colorado Denver | Anschutz Medical Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Tobias Eckel, MD, PhD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

December 28, 2020

Study Completion (Actual)

December 28, 2020

Study Registration Dates

First Submitted

June 24, 2015

First Submitted That Met QC Criteria

July 1, 2015

First Posted (Estimate)

July 3, 2015

Study Record Updates

Last Update Posted (Actual)

June 7, 2021

Last Update Submitted That Met QC Criteria

June 2, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-1607

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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