Day Light for Ischemia

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Colorado Denver | Anschutz Medical Campus, Denver, CO
Ischemia+3 More
Day Light - Device
Eligibility
18+
All Sexes
Eligible conditions
Ischemia

Study Summary

This study is evaluating whether light therapy may help reduce the risk of heart attacks and other complications following cardiac surgery.

See full description

Eligible Conditions

  • Ischemia
  • Critical Illness
  • Myocardial Ischemia
  • Endothelial Dysfunction

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Day Light will improve 1 primary outcome in patients with Ischemia. Measurement will happen over the course of 1-10 days.

1-10 days
Change of Period 2 (Per2) protein levels

Trial Safety

Trial Design

4 Treatment Groups

Sham Comparator: Exposed to Room light
Experimental: ICU Exposed to Day light
Placebo group

This trial requires 70 total participants across 4 different treatment groups

This trial involves 4 different treatments. Day Light is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Experimental: ICU Exposed to Day light
Device
Patients undergoing trauma or elective surgery with ICU admission: Light therapy will consist of 30 minutes intense light each morning for 5-10 days. Blood will be drawn before sunrise and after light therapy. Light therapy will be performed by a study nurse to ensure proper use. In addition, endothelial function and activity will be measured using the noninvasive Endo-pat and ActiWatch device. The patient will need to keep the box as close as possible to their eyes and not walk away during the treatment period. This will be facilities by a study nurse.
Experimental: Exposed to Day light
Device
Patients undergoing primary sternotomy cardiac surgery: Patients will be enrolled 10 to 1 days prior to surgery and will receive an intense (bright light, Square One Wake Up Light NatureBright 10,000 LUX) box. The patient will start using the light box prior to surgery every morning from 8.30 to 9.00 AM. Blood /buccal swabs will be collected on the day of enrollment (10 to 1 days prior to surgery) between 7 and 10 AM without any light therapy and on the day of surgery between 7 and 10 AM before anesthesia induction after one week of light therapy.
Sham Comparator: Exposed to Room light
Device
Patients undergoing primary sternotomy cardiac surgery: Patients will be enrolled 10 to 1 days prior to surgery and will receive a placebo/control device (dim/night light box). The patient will start using the light box 7 days prior to surgery every morning from 8.30 to 9.00 AM. Blood /buccal swabs will be collected on the day of enrollment (10 to 1 days prior to surgery) between 7 and 10 AM without any light therapy and on the day of surgery between 7 and 10 AM before anesthesia induction after one week of placebo therapy.
Sham Comparator: ICU Exposed to Room light
Device
Patients undergoing trauma or elective surgery with ICU admission: Light therapy will consist of 30 minutes using a placebo/control device (dim/night light box) each morning for 5-10 days. Blood will be drawn before sunrise and after light therapy. Light therapy will be performed by a study nurse to ensure proper use. In addition, endothelial function and activity will be measured using the noninvasive Endo-pat and ActiWatch device.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1-10 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1-10 days for reporting.

Closest Location

University of Colorado Denver | Anschutz Medical Campus - Denver, CO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients undergoing primary sternotomy cardiac surgery
The study focuses on people aged 18 to 90. show original
It is necessary for the patient to be in sinus rhythm in order for surgery to be successful. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can ischemia be cured?

Add answer

Ischemia is not the cause of the core lesion in the anterior lobe; lesions in the periphery of the lobe are most likely to cause ischemia. The lesions that cause a core necrosis are not the source of the infarct because the source of the infarct is not a core lesion in the right or left lobe. Rather, infarction occurs because of an embolic cascade.

Unverified Answer

What are the signs of ischemia?

Add answer

The patient will usually have no previous symptoms and will be a fit or moderately active individual. The symptoms that occur as a result of ischemia are often subtle with symptoms that arise once the acute phase has passed. Because of the potential for the symptoms to be attributed to other illnesses, a thorough history and physical examination to rule out causes that are common will maximize diagnostic accuracy.

Unverified Answer

What causes ischemia?

Add answer

Stroke is most common in very old people, people who are disabled and who have undergone major surgery. The cause is believed to be stroke or a sudden arterial blockage caused by atherosclerotic plaque in the aorta.

Unverified Answer

How many people get ischemia a year in the United States?

Add answer

The data indicated that the frequency of ischemia in the U.S (21% +/- 9%) was comparable to that seen in Europe (27%). There was, however, no difference between the genders. This information supports the notion that in the U.S, ischemia may not be a significant factor in determining morbidity and mortality.

Unverified Answer

What is ischemia?

Add answer

Ischemia can arise from a number of mechanisms, including peripheral artery disease, myocardial infarction, embolism, kidney obstruction, stroke, and cardiac arrhythmia. Treatment of ischemia often includes reperfusion therapy.\n

Unverified Answer

What are common treatments for ischemia?

Add answer

Most ischemia is due to vascular disease, coronary artery disease, peripheral artery disease, or diabetes. Common treatments for ischemia include atherosclerotic medical treatments, revascularization interventions, and antiplatelet therapy. A systematic review of current evidence indicates that some of these treatments are more effective than others.

Unverified Answer

Have there been any new discoveries for treating ischemia?

Add answer

In terms of therapeutic strategies for repairing or replacing damaged myocardium, the results of these trials indicate that further research is needed. There is considerable potential for improved patient outcomes by combining drugs and device technology to treat ischemia for myocardial infarction, and that this new technology will likely be available before the end of this century.

Unverified Answer

Is day light typically used in combination with any other treatments?

Add answer

In this review, only one study showed the effectiveness in decreasing disease progression of DLP therapy. The authors suggest that the most important parameter in any study of DLP using a clinical trial design as opposed to a clinical trial on DLP as a monotherapy, is the combination of two or three treatments together with DLP (if it can be used as a monotherapy). At present, in general, we advocate combination therapy with DLP.

Unverified Answer

How serious can ischemia be?

Add answer

Ischemia lasts in the brain up to 30 days. However, only 15% of acute ischemic stroke patients will experience transient aphasia with normal neurological examination. This may be due to the presence of large proximal vessel occlusion. In a small minority of cases, the presence of a persistent deficit may be the result of delayed tissue death and not of ischemic damage.

Unverified Answer

Is day light safe for people?

Add answer

Patients who report that they have more difficulty falling asleep or with noctrainers in the early morning should be particularly alarmed about day light exposure.

Unverified Answer

What are the latest developments in day light for therapeutic use?

Add answer

The data on the effect of light exposure on endothelial function and blood pressure have been reported in a recent report. Results from a recent clinical trial clearly suggest that the most promising therapeutic uses of the light radiation are the cosmetic effects such as skin rejuvenation and anti-aging and the therapeutic benefits of treatment of blood pressure and arterial thrombosis. These new cosmetic/therapeutic uses are still the subjects of further investigation.

Unverified Answer

Does ischemia run in families?

Add answer

Recent findings revealed a significant relationship between ischemic cerebrovascular diseases and family history of the trait in the sample. As the data obtained is of great help in clinical practice of preventive and personalized medicine, more studies need to be conducted for wider applicability.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Ischemia by sharing your contact details with the study coordinator.