Cardiac period 2 in myocardial ischemia: clinical implications of a light dependent protein.
Stephanie Bonney, Kelly Hughes, Patrick N Harter...
https://pubmed.ncbi.nlm.nih.gov/23291353/Actively Recruiting
Led by University of Colorado, Denver · Updated on 2025-05-14
70
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the effects of intense light therapy on patients undergoing cardiac surgery and those critically ill in intensive care units. The study explores how bright light exposure may stabilize the Per2 protein in blood and tissue samples, potentially reducing heart muscle damage after surgery. It also investigates how light therapy might improve circadian rhythms and blood vessel function in critically ill patients to prevent complications like strokes and organ damage. Participants scheduled for primary sternotomy cardiac surgery will be randomly assigned to receive either bright light therapy or a dim placebo light for up to 10 days before surgery. The therapy involves using a bright light box for 30 minutes each morning between 830 and 900 AM. For ICU patients after trauma or elective surgery, intense light therapy or placebo light will be applied for 30 minutes each morning for 5 to 10 days. During the study, blood and buccal swabs will be collected, and a small piece of heart tissue will be taken during surgery for analysis. Noninvasive devices will monitor blood vessel function and circadian activity. Throughout participation, patients will undergo blood draws before and after light therapy, including measurements of Per2 levels, Troponin I, melatonin, triglycerides, and ANGPTL4. Endothelial function will be assessed using the Endo-PAT device, and circadian patterns will be tracked with an Actiwatch worn on the wrist. Light therapy will be supervised to ensure proper use. The study aims to understand whether light exposure can reduce heart injury during surgery and improve blood vessel function in critically ill patients, with monitoring continuing up to 10 days and beyond.
CONDITIONS
Bright Light Exposure in Surgical Patients
T
Tobias Eckle, MD, PhD
N
Nick Naughton, BS
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University of Colorado, Denver
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Daylight exposure | Placebo light exposure |
|---|---|---|
| What it is | A device-based daylight exposure applied up to 10 days before surgery and in the ICU after surgery | A sham placebo light exposure applied up to 10 days before surgery and in the ICU after surgery |
| Role in trial | Investigational intervention intended to promote perioperative protection via light exposure | Sham control to compare against daylight exposure |
| Primary use | Being studied for prevention of perioperative myocardial ischemia (measured via Per2 protein levels) | Used as a sham control to evaluate daylight exposure effect |
| How it is given or performed | Light device provides daylight exposure up to 10 days before surgery and after surgery in the ICU | Sham light device follows same timing but emits placebo light |
| Evidence status | No results available yet; effect on Per2 protein levels under evaluation | No results available for sham comparator |
| Important limitations | Results not yet available; unknown whether daylight exposure influences clinical myocardial outcomes | Sham comparator offers no active intervention; effect size is unclear without results |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) between 10 to 1 days prior to surgery for blood and buccal swab collection without light therapy
Duration - 7 days prior to surgery
Participants start using a light box device every morning from 8:30 to 9:00 AM for 7 days prior to surgery. Participants must keep the device close to their eyes and remain in place during exposure.
Daily self-administered light therapy sessions each morning for 7 days
Duration - Day of surgery
Participants undergo cardiac surgery. Blood and tissue samples are collected on the day of surgery before anesthesia induction after one week of light or placebo therapy. A small piece of right atrial myocardium is collected during surgery for analysis.
1 visit (in-person) for surgery and sample collection
Duration - Up to 10 days after surgery
Participants admitted to ICU receive daily 30-minute light therapy or placebo light each morning for 5 to 10 days. Blood samples are drawn before sunrise and after light therapy each day. Noninvasive monitoring of endothelial function and circadian patterns is performed with Endo-PAT and ActiWatch devices.
Daily visits or assessments for up to 10 days post-surgery in ICU
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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Stephanie Bonney, Kelly Hughes, Patrick N Harter...
https://pubmed.ncbi.nlm.nih.gov/23291353/Yoshimasa Oyama, Colleen Marie Bartman, Jennifer Gile...
https://pubmed.ncbi.nlm.nih.gov/28699517/Yoshimasa Oyama, Colleen Marie Bartman, Jennifer Gile...
https://pubmed.ncbi.nlm.nih.gov/30246635/Stephanie Bonney, Doug Kominsky, Kelley Brodsky...
https://pubmed.ncbi.nlm.nih.gov/23977055/Tobias Eckle, Katherine Hartmann, Stephanie Bonney...
https://pubmed.ncbi.nlm.nih.gov/22504483/Colleen Marie Bartman, Yoshimasa Oyama, Kelley Brodsky...
https://pubmed.ncbi.nlm.nih.gov/28448534/Colleen M Bartman, Yoshimasa Oyama, Tobias Eckle
https://pubmed.ncbi.nlm.nih.gov/29856340/University of Colorado, Denver
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor