Myocardial IschemiaNCT03822949
Bright Light Exposure in Surgical Patients
A study testing Day Light and ICU Intense Light in people with Myocardial Ischemia and Critical Illness, run by University of Colorado, Denver at 1 site in United States.
Trial summary
1. Elucidate the influence of intense light therapy pretreatment in patients undergoing cardiac surgery. We hypothesize that intense light exposure is associated with the peripheral stabilization of Per2 in human buccal swabs and plasma samples before surgery and with a decrease of Troponin I levels after surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Myocardial Ischemia, Critical Illness, Endothelial Dysfunction
- What is being tested?
- Day Light and ICU Intense Light
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2019to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing primary sternotomy cardiac surgery
- Subjects in the range of 18 - 90 years old .
- Patient need to be in sinus rhythm at the time of surgery.
Who cannot join
- patients <18 or >90 years old
- participation in other clinical trials within the previous 30 days
- pregnancy
- neurological conditions that could impair weaning from ventilator support
- significant CNS disorders or comorbid irreversible conditions with a six-month mortality rate more than 50 percent
- prisoners, or subjects with altered capabilities to make decision will be enrolled
Show all 10Show fewer
- medical history of type 2 diabetes
- patients with atrial fibrillation or use of class III anti-arhythmic drug
- patients with a left ventricle ejection fraction < 40%
- patient in emergency condition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Denver | Anschutz Medical Campus
Denver, Colorado, 80220-3706
Nick M Naughton, BS, 303-724-0833, NICK.NAUGHTON@CUANSCHUTZ.EDU
About this study
Official title: Bright Light Exposure in Patients Undergoing Non-cardiac Elective Surgery
- Elucidate the influence of intense light therapy pretreatment in patients undergoing cardiac surgery. We hypothesize that intense light exposure is associated with the peripheral stabilization of Per2 in human buccal swabs and plasma samples before surgery and with a decrease of Troponin I levels after surgery. In addition, we hypothesize that light therapy leads to Per2 dependent metabolic optimization in the human cardiac tissue. Therefore, a small piece of human heart tissue from the right atrium will be collected during cardiac cannulation, which will be otherwise discarded.
- Critical illness (being in the intensive care unit) results in circadian malfunction and vessels not working. Vessel function is controlled by the body's circadian clock. Intense light boosts the circadian clock and the vessel function in animal studies. Vessels not working well in critical ill patients results in a myriad of severe diseases (delirium, stroke, heart attack, organ damage etc). Thus we will test if intense light can be used to boost the circadian clock and the associated vessel function in critical ill patients.
Read the detailed description
PER2 transcript and protein levels in patients undergoing cardiac surgery following intense light therapy utilizing blood samples, buccal swaps and right atrial myocardium. In addition, we will examine the correlation of PER2 levels and PER2 related metabolism and perform a whole genome microarray screen from the collected tissue/blood samples.
Patients will be enrolled 10 to 1 days prior to surgery and will either receive an intense (bright light) box or 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. The patient will need to keep the box as close as possible to their eyes and not walk away during the treatment period.
- Blood /buccal swabs will be collected on the day of enrollment (10-1 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/placebo therapy. A small piece of the right atrial myocardium (which stems from cardiac cannulation and is otherwise discarded) will be put in liquid nitrogen in the OR and stored for further analysis. In addition, we will draw a blood sample 72 hrs. after surgery and determine Troponin I levels. Investigating this patient population will give the necessary evidence if light could also be effective in a perioperative setting to prevent or decrease damage to the myocardium during high risk cardiac surgery. In addition, it will help us understand if light could be used in general to prevent or treat heart ischemia.
- We will use our light boxes for 30 minutes in ICU care patients on the first morning after admission from 8.30 to 9.00 AM. Before light therapy/sunrise and immediately after light therapy, a blood sample is drawn. These samples will be analyzed for melatonin levels. We have demonstrated that effective intense blue intense light therapy significantly suppresses melatonin plasma levels in health human volunteers which is the desired outcome of light therapy. We also have shown that light exposure via windows does not achieve such a result. Light therapy will be continued for up to 10 days, and blood samples are drawn each morning before sunrise and after light therapy. In patients that are sedated and have their eyes closed, eyes will be opened manually and lubricated before light therapy is initiated. The sample size will be n=40 (10 light treatment 5 days, 10 light treatment 10 days and 10 standard room light treatment 5 and 10 days). Additional readouts from plasma sample will be triglyceride and ANGPTL4 levels as we have already shown that intense light significantly downregulates triglycerides in healthy volunteers. Further, we recently discovered ANGPTL4 as major light dependent protein. ANGPTL4 is a key regulator of triglycerides and of endothelial function in humans and triglyceride levels are also indicative of endothelial function. This approach will allow us to evaluate the effectiveness of our light therapy approach and will further give insight into light elicited endothelial mechanisms in humans.
To further study endothelial function, we will use the Endo_PAT device (Itamar Medical Ltd, Franklin, MA) which has been shown to reliably detect endothelial dysfunction and alterations in critical ill patients. This device has been shown to even work when patients who are on vasopressor therapy. This device is noninvasive and works like an SpO2 monitor with built in cuff pressure measurement.
Finally, we will use Actigraphy (Actiwatch, Phillips) to analyze circadian patterns and associated changes following light therapy. We already have purchased FDA approved Actigraphy devices and shown that intense light strengthens the circadian rhythms in healthy volunteers. Watches will be around the wrist for the duration of the light therapy and are noninvasive.
- Being tested
- Day Light, Placebo light, ICU Intense Light, ICU Placebo light
- Medical subject headings
- Myocardial Ischemia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Day LightDevice
Patients are exposed to daylight for up to 10 days prior to surgery
Placebo lightDevice
Patients are exposed to placebo light for up to 10 days prior to surgery
ICU Intense LightDevice
ICU Patients are exposed to daylight for up to 10 days after surgery
ICU Placebo lightDevice
ICU Patients are exposed to placebo light for up to 10 days after surgery
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Exposed to Day light | Experimental | 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. Receives: Device: Day Light |
| Sham Comparator: Exposed to Room light | Placebo comparator | 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. Receives: Device: Placebo light |
| Experimental: ICU Exposed to Day light | Experimental | 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. Receives: Device: ICU Intense Light |
| Sham Comparator: ICU Exposed to Room light | Placebo comparator | 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. Receives: Device: ICU Placebo light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Period 2 (Per2) protein levels
Measure of Per2 protein levels related to daylight exposure vs. room light exposure.
Measured: 1-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start12 Jul 2019
- Primary completionJul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Tobias Eckle, MD, PhD, Principal investigator, UC Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822949
- Sponsor's protocol ID
- 18-0904
- Other IDs
- R01HL122472
- Status last verified
- May 2025
- First submitted
- 27 Jan 2019
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bartman CM, Oyama Y, Eckle T. Daytime variations in perioperative myocardial injury. Lancet. 2018 May 26;391(10135):2104. doi: 10.1016/S0140-6736(18)30797-9. Epub 2018 May 24. No abstract available.
PubMed 29856340Oyama Y, Bartman CM, Gile J, Eckle T. Circadian MicroRNAs in Cardioprotection. Curr Pharm Des. 2017;23(25):3723-3730. doi: 10.2174/1381612823666170707165319.
PubMed 28699517Bonney S, Hughes K, Harter PN, Mittelbronn M, Walker L, Eckle T. Cardiac period 2 in myocardial ischemia: clinical implications of a light dependent protein. Int J Biochem Cell Biol. 2013 Mar;45(3):667-71. doi: 10.1016/j.biocel.2012.12.022. Epub 2013 Jan 3.
PubMed 23291353Oyama Y, Bartman CM, Gile J, Sehrt D, Eckle T. The Circadian PER2 Enhancer Nobiletin Reverses the Deleterious Effects of Midazolam in Myocardial Ischemia and Reperfusion Injury. Curr Pharm Des. 2018;24(28):3376-3383. doi: 10.2174/1381612824666180924102530.
PubMed 30246635Bartman CM, Oyama Y, Brodsky K, Khailova L, Walker L, Koeppen M, Eckle T. Intense light-elicited upregulation of miR-21 facilitates glycolysis and cardioprotection through Per2-dependent mechanisms. PLoS One. 2017 Apr 27;12(4):e0176243. doi: 10.1371/journal.pone.0176243. eCollection 2017.
PubMed 28448534Bonney S, Kominsky D, Brodsky K, Eltzschig H, Walker L, Eckle T. Cardiac Per2 functions as novel link between fatty acid metabolism and myocardial inflammation during ischemia and reperfusion injury of the heart. PLoS One. 2013 Aug 20;8(8):e71493. doi: 10.1371/journal.pone.0071493. eCollection 2013.
PubMed 23977055Eckle 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.
PubMed 22504483
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bright Light Exposure in Patients Undergoing Non-cardiac Elective Surgery
- ClinicalTrials.gov ID
- NCT03822949
- Acronym / sponsor ID
- 18-0904
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 12 Jul 2019 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Elucidate the influence of intense light therapy pretreatment in patients undergoing cardiac surgery. We hypothesize that intense light exposure is associated with the peripheral stabilization of Per2 in human buccal swabs and plasma samples before surgery and with a decrease of Troponin I levels after surgery. In addition, we hypothesize that light therapy leads to Per2 dependent metabolic optimization in the human cardiac tissue. Therefore, a small piece of human heart tissue from the right atrium will be collected during cardiac cannulation, which will be otherwise discarded.
- Critical illness (being in the intensive care unit) results in circadian malfunction and vessels not working. Vessel function is controlled by the body's circadian clock. Intense light boosts the circadian clock and the vessel function in animal studies. Vessels not working well in critical ill patients results in a myriad of severe diseases (delirium, stroke, heart attack, organ damage etc). Thus we will test if intense light can be used to boost the circadian clock and the associated vessel function in critical ill patients.
Detailed description
PER2 transcript and protein levels in patients undergoing cardiac surgery following intense light therapy utilizing blood samples, buccal swaps and right atrial myocardium. In addition, we will examine the correlation of PER2 levels and PER2 related metabolism and perform a whole genome microarray screen from the collected tissue/blood samples.
Patients will be enrolled 10 to 1 days prior to surgery and will either receive an intense (bright light) box or 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. The patient will need to keep the box as close as possible to their eyes and not walk away during the treatment period.
- Blood /buccal swabs will be collected on the day of enrollment (10-1 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/placebo therapy. A small piece of the right atrial myocardium (which stems from cardiac cannulation and is otherwise discarded) will be put in liquid nitrogen in the OR and stored for further analysis. In addition, we will draw a blood sample 72 hrs. after surgery and determine Troponin I levels. Investigating this patient population will give the necessary evidence if light could also be effective in a perioperative setting to prevent or decrease damage to the myocardium during high risk cardiac surgery. In addition, it will help us understand if light could be used in general to prevent or treat heart ischemia.
- We will use our light boxes for 30 minutes in ICU care patients on the first morning after admission from 8.30 to 9.00 AM. Before light therapy/sunrise and immediately after light therapy, a blood sample is drawn. These samples will be analyzed for melatonin levels. We have demonstrated that effective intense blue intense light therapy significantly suppresses melatonin plasma levels in health human volunteers which is the desired outcome of light therapy. We also have shown that light exposure via windows does not achieve such a result. Light therapy will be continued for up to 10 days, and blood samples are drawn each morning before sunrise and after light therapy. In patients that are sedated and have their eyes closed, eyes will be opened manually and lubricated before light therapy is initiated. The sample size will be n=40 (10 light treatment 5 days, 10 light treatment 10 days and 10 standard room light treatment 5 and 10 days). Additional readouts from plasma sample will be triglyceride and ANGPTL4 levels as we have already shown that intense light significantly downregulates triglycerides in healthy volunteers. Further, we recently discovered ANGPTL4 as major light dependent protein. ANGPTL4 is a key regulator of triglycerides and of endothelial function in humans and triglyceride levels are also indicative of endothelial function. This approach will allow us to evaluate the effectiveness of our light therapy approach and will further give insight into light elicited endothelial mechanisms in humans.
To further study endothelial function, we will use the Endo_PAT device (Itamar Medical Ltd, Franklin, MA) which has been shown to reliably detect endothelial dysfunction and alterations in critical ill patients. This device has been shown to even work when patients who are on vasopressor therapy. This device is noninvasive and works like an SpO2 monitor with built in cuff pressure measurement.
Finally, we will use Actigraphy (Actiwatch, Phillips) to analyze circadian patterns and associated changes following light therapy. We already have purchased FDA approved Actigraphy devices and shown that intense light strengthens the circadian rhythms in healthy volunteers. Watches will be around the wrist for the duration of the light therapy and are noninvasive.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental: Exposed to Day light | Experimental | Device: Day LightPatients 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 | Placebo comparator | Device: Placebo lightPatients 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. |
| Experimental: ICU Exposed to Day light | Experimental | Device: ICU Intense LightPatients 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. |
| Sham Comparator: ICU Exposed to Room light | Placebo comparator | Device: ICU Placebo lightPatients 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing primary sternotomy cardiac surgery
- Subjects in the range of 18 - 90 years old .
- Patient need to be in sinus rhythm at the time of surgery.
Key exclusion criteria (10 listed)
- patients <18 or >90 years old
- participation in other clinical trials within the previous 30 days
- pregnancy
- neurological conditions that could impair weaning from ventilator support
- significant CNS disorders or comorbid irreversible conditions with a six-month mortality rate more than 50 percent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Day LightPatients are exposed to daylight for up to 10 days prior to surgery | Device | Experimental: Exposed to Day light |
| Placebo lightPatients are exposed to placebo light for up to 10 days prior to surgery | Device | Sham Comparator: Exposed to Room light |
| ICU Intense LightICU Patients are exposed to daylight for up to 10 days after surgery | Device | Experimental: ICU Exposed to Day light |
| ICU Placebo lightICU Patients are exposed to placebo light for up to 10 days after surgery | Device | Sham Comparator: ICU Exposed to Room light |
Primary outcome
Change of Period 2 (Per2) protein levels
Time frame: 1-10 days
Measure of Per2 protein levels related to daylight exposure vs. room light exposure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Background: PubMed 29856340Bartman CM, Oyama Y, Eckle T. Daytime variations in perioperative myocardial injury. Lancet. 2018 May 26;391(10135):2104. doi: 10.1016/S0140-6736(18)30797-9. Epub 2018 May 24. No abstract available.
- Background: PubMed 28699517Oyama Y, Bartman CM, Gile J, Eckle T. Circadian MicroRNAs in Cardioprotection. Curr Pharm Des. 2017;23(25):3723-3730. doi: 10.2174/1381612823666170707165319.
- Background: PubMed 23291353Bonney S, Hughes K, Harter PN, Mittelbronn M, Walker L, Eckle T. Cardiac period 2 in myocardial ischemia: clinical implications of a light dependent protein. Int J Biochem Cell Biol. 2013 Mar;45(3):667-71. doi: 10.1016/j.biocel.2012.12.022. Epub 2013 Jan 3.
- Results publication: PubMed 30246635Oyama Y, Bartman CM, Gile J, Sehrt D, Eckle T. The Circadian PER2 Enhancer Nobiletin Reverses the Deleterious Effects of Midazolam in Myocardial Ischemia and Reperfusion Injury. Curr Pharm Des. 2018;24(28):3376-3383. doi: 10.2174/1381612824666180924102530.
- Results publication: PubMed 28448534Bartman CM, Oyama Y, Brodsky K, Khailova L, Walker L, Koeppen M, Eckle T. Intense light-elicited upregulation of miR-21 facilitates glycolysis and cardioprotection through Per2-dependent mechanisms. PLoS One. 2017 Apr 27;12(4):e0176243. doi: 10.1371/journal.pone.0176243. eCollection 2017.
- Results publication: PubMed 23977055Bonney S, Kominsky D, Brodsky K, Eltzschig H, Walker L, Eckle T. Cardiac Per2 functions as novel link between fatty acid metabolism and myocardial inflammation during ischemia and reperfusion injury of the heart. PLoS One. 2013 Aug 20;8(8):e71493. doi: 10.1371/journal.pone.0071493. eCollection 2013.
- Results publication: PubMed 22504483Eckle 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tobias Eckle, MD, PhD principal investigator
UC Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Day Light and ICU Intense Light in people with Myocardial Ischemia and Critical Illness, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tobias Eckle, MD, PhD (7209495646, tobias.eckle@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Period 2 (Per2) protein levels (time frame: 1-10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03822949, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025; AzTrials last refreshed its copy on 3 Nov 2026.