Coronary Artery Bypass and Nitrate Oral Supplementation

Coronary Artery Disease Clinical Trial

— CABANOS  

Official title:

Effects of Oral Nitrate During Coronary Artery Bypass Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01348971
• Other study ID #: KI-101
• Status: Completed
• Phase: Phase 2
• First received: May 4, 2011
• Last updated: September 24, 2013
• Start date: March 2011
• Est. completion date: February 2013

Study information

• Verified date: September 2013
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients undergoing coronary artery bypass surgery

• Over 18 years of age

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Dietary Supplement:
• Sodium nitrate
Preoperative oral administration of sodium nitrate. 700 mg the night before surgery and 700 mg three hours before surgery

Other:
• Sodium chloride
Preoperative oral administration of sodium chloride the night before surgery and three hours before surgery

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Troponin T release over the perioperative 72-hour period.		72 hours	No
Secondary	Troponin T release over the perioperative 24-hour period.		24 h	No
Secondary	Creatinine kinase myocardial fraction (CKMB) release over the perioperative 72-hour period		72 hours	No
Secondary	Creatinine kinase myocardial fraction (CKMB) release over the perioperative 24-hour period		24 hours	No
Secondary	Pro Brain natriuretic peptide (proBNP) release over the perioperative 72-hour period.		72 hours	No
Secondary	Aspartate aminotransferase (AST) release over the perioperative 72-hour period.		72 hours	No
Secondary	Alaninaminotransferas (ALAT) release over the perioperative 72-hour period.		72 hours	No
Secondary	Alkaline phosphatase (ALP) release over the perioperative 72-hour period.		72 hours	No
Secondary	Bilirubin release over the perioperative 72-hour period		72 hours	No
Secondary	Creatinine release over the perioperative 72-hour period		72 h	No
Secondary	Cystatin C release over the perioperative 72-hour period		72	No