Coronary Artery DiseasePhase 2CABANOSNCT01348971
Coronary Artery Bypass and Nitrate Oral Supplementation
A Phase 2 study testing Sodium nitrate and Sodium chloride in people with Coronary Artery Disease, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether oral sodium nitrate administration prior to coronary artery bypass surgery can reduce perioperative levels of troponin T. In addition, plasma and urine surrogate markers of renal, hepatic and brain injury will be monitored. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Sodium nitrate and Sodium chloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2011to Feb 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing coronary artery bypass surgery
- Over 18 years of age
Who cannot join
- Over 80 years of age
- Pregnancy
- Reoperation
- Intended heart valve or additional surgery
- Angina or troponin release above 45 nmol/L < 48 hours before surgery
- Medication with organic nitrates/nitrites < 24 hours before surgery
- Medication with glibenclamide or corticosteroids
- Significant renal, pulmonary or hepatic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Oral Nitrate During Coronary Artery Bypass Surgery
The purpose of this study is to determine whether oral sodium nitrate administration prior to coronary artery bypass surgery can reduce perioperative levels of troponin T. In addition, plasma and urine surrogate markers of renal, hepatic and brain injury will be monitored.
Read the detailed description
Nitric oxide (NO) is an important mediator in the cardiovascular system and has been shown to have protective properties in ischemia-reperfusion injury. Inorganic nitrate, an oxidation product from endogenous NO production and also a constituent in green leafy vegetables, can be recycled, via nitrite, back to bioactive NO in the body. Recent research has shown beneficial effects of nitrate and nitrite in animal models of myocardial ischemia-reperfusion injury. Moreover, dietary nitrate reduces blood pressure and oxygen cost during exercise in humans.
During coronary bypass surgery the heart undergoes ischemia-reperfusion injury and troponin T is most often released from the myocardium. The aim of the present study is to investigate if preoperative inorganic nitrate, in doses easily achievable from the diet, can affect troponin T release as well as other surrogate markers of injury to the liver, kidneys and the brain. In addition, plasma and urine samples will be collected for markers of oxidative stress and inflammation (sCRP and cytokines). Patients planned for bypass surgery who give their written informed consent will, the night before surgery, get a standardized, low-nitrate meal where after they receive sodium nitrate on two occasions preoperatively; the night before and in the morning before surgery. Plasma and urine samples will be collected at various time points up to 72 hours after surgery.
- Conditions
- Coronary Artery Disease
- Being tested
- Sodium nitrate, Sodium chloride
- Keywords
- sodium nitrate, coronary artery bypass surgery, ischemia-reperfusion, myocardial injury
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium nitrateDietary supplement
Preoperative oral administration of sodium nitrate. 700 mg the night before surgery and 700 mg three hours before surgery
Sodium chlorideOther
Preoperative oral administration of sodium chloride the night before surgery and three hours before surgery
| Study group | Role | What they receive |
|---|---|---|
| Sodium nitrate | Experimental | Preoperative oral administration of sodium nitrate. 700 mg the night before surgery and 700 mg three hours before surgery Receives: Dietary Supplement: Sodium nitrate |
| Placebo | Placebo comparator | Preoperative oral administration of sodium chloride the night before surgery and three hours before surgery Receives: Other: Sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Troponin T release over the perioperative 72-hour period.
Measured: 72 hours
Secondary outcomes (10)
Troponin T release over the perioperative 24-hour period.
Measured: 24 h
Creatinine kinase myocardial fraction (CKMB) release over the perioperative 72-hour period
Measured: 72 hours
Creatinine kinase myocardial fraction (CKMB) release over the perioperative 24-hour period
Measured: 24 hours
Pro Brain natriuretic peptide (proBNP) release over the perioperative 72-hour period.
Measured: 72 hours
Aspartate aminotransferase (AST) release over the perioperative 72-hour period.
Measured: 72 hours
Alaninaminotransferas (ALAT) release over the perioperative 72-hour period.
Measured: 72 hours
Alkaline phosphatase (ALP) release over the perioperative 72-hour period.
Measured: 72 hours
Bilirubin release over the perioperative 72-hour period
Measured: 72 hours
Creatinine release over the perioperative 72-hour period
Measured: 72 h
Cystatin C release over the perioperative 72-hour period
Measured: 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2011 (estimated)
- Study startMar 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eddie Weitzberg, Karolinska Institutet
- Investigators
- Eddie T Weitzberg, MD,PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348971
- Sponsor's protocol ID
- KI-101
- Acronym
- CABANOS
- Status last verified
- Sep 2013
- First submitted
- 4 May 2011
- Last updated
- 26 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Eriksson KE, Eidhagen F, Liska J, Franco-Cereceda A, Lundberg JO, Weitzberg E. Effects of inorganic nitrate on ischaemia-reperfusion injury after coronary artery bypass surgery: a randomised controlled trial. Br J Anaesth. 2021 Oct;127(4):547-555. doi: 10.1016/j.bja.2021.06.046. Epub 2021 Aug 14.
PubMed 34399982
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Nitrate During Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT01348971
- Acronym / sponsor ID
- CABANOS / KI-101
- Conditions
- Coronary Artery Disease
- Keywords
- sodium nitrate, coronary artery bypass surgery, ischemia-reperfusion, myocardial injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 6 May 2011 (estimated)
- 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.
The purpose of this study is to determine whether oral sodium nitrate administration prior to coronary artery bypass surgery can reduce perioperative levels of troponin T. In addition, plasma and urine surrogate markers of renal, hepatic and brain injury will be monitored.
Detailed description
Nitric oxide (NO) is an important mediator in the cardiovascular system and has been shown to have protective properties in ischemia-reperfusion injury. Inorganic nitrate, an oxidation product from endogenous NO production and also a constituent in green leafy vegetables, can be recycled, via nitrite, back to bioactive NO in the body. Recent research has shown beneficial effects of nitrate and nitrite in animal models of myocardial ischemia-reperfusion injury. Moreover, dietary nitrate reduces blood pressure and oxygen cost during exercise in humans.
During coronary bypass surgery the heart undergoes ischemia-reperfusion injury and troponin T is most often released from the myocardium. The aim of the present study is to investigate if preoperative inorganic nitrate, in doses easily achievable from the diet, can affect troponin T release as well as other surrogate markers of injury to the liver, kidneys and the brain. In addition, plasma and urine samples will be collected for markers of oxidative stress and inflammation (sCRP and cytokines). Patients planned for bypass surgery who give their written informed consent will, the night before surgery, get a standardized, low-nitrate meal where after they receive sodium nitrate on two occasions preoperatively; the night before and in the morning before surgery. Plasma and urine samples will be collected at various time points up to 72 hours after surgery.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium nitrate | Experimental | Dietary Supplement: Sodium nitratePreoperative oral administration of sodium nitrate. 700 mg the night before surgery and 700 mg three hours before surgery |
| Placebo | Placebo comparator | Other: Sodium chloridePreoperative oral administration of sodium chloride the night before surgery and three hours before surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing coronary artery bypass surgery
- Over 18 years of age
Key exclusion criteria (8 listed)
- Over 80 years of age
- Pregnancy
- Reoperation
- Intended heart valve or additional surgery
- Angina or troponin release above 45 nmol/L < 48 hours before surgery
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 |
|---|---|---|
| Sodium nitratePreoperative oral administration of sodium nitrate. 700 mg the night before surgery and 700 mg three hours before surgery | Dietary supplement | Sodium nitrate |
| Sodium chloridePreoperative oral administration of sodium chloride the night before surgery and three hours before surgery | Other | Placebo |
Primary outcome
Troponin T release over the perioperative 72-hour period.
Time frame: 72 hours
10 secondary outcomes
Troponin T release over the perioperative 24-hour period.
Time frame: 24 h
Creatinine kinase myocardial fraction (CKMB) release over the perioperative 72-hour period
Time frame: 72 hours
Creatinine kinase myocardial fraction (CKMB) release over the perioperative 24-hour period
Time frame: 24 hours
Pro Brain natriuretic peptide (proBNP) release over the perioperative 72-hour period.
Time frame: 72 hours
Aspartate aminotransferase (AST) release over the perioperative 72-hour period.
Time frame: 72 hours
Alaninaminotransferas (ALAT) release over the perioperative 72-hour period.
Time frame: 72 hours
Alkaline phosphatase (ALP) release over the perioperative 72-hour period.
Time frame: 72 hours
Bilirubin release over the perioperative 72-hour period
Time frame: 72 hours
Creatinine release over the perioperative 72-hour period
Time frame: 72 h
Cystatin C release over the perioperative 72-hour period
Time frame: 72
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2013.
- Derived from this study: PubMed 34399982Eriksson KE, Eidhagen F, Liska J, Franco-Cereceda A, Lundberg JO, Weitzberg E. Effects of inorganic nitrate on ischaemia-reperfusion injury after coronary artery bypass surgery: a randomised controlled trial. Br J Anaesth. 2021 Oct;127(4):547-555. doi: 10.1016/j.bja.2021.06.046. Epub 2021 Aug 14.
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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. This study is not recruiting at the moment.
Eddie T Weitzberg, MD,PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium nitrate and Sodium chloride in people with Coronary Artery Disease, run by Karolinska Institutet at 1 site in Sweden.
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 26 Sep 2013. 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 Sweden. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Troponin T release over the perioperative 72-hour period. (time frame: 72 hours). 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 NCT01348971, which also lists 1 linked publication.
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 26 Sep 2013.