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Coronary Artery Bypass and Nitrate Oral Supplementation (CABANOS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Karolinska Institutet.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01348971
First received: May 4, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
 Dietary Supplement: Sodium nitrate
Other: Sodium chloride
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Oral Nitrate During Coronary Artery Bypass Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Troponin T release over the perioperative 72-hour period. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Troponin T release over the perioperative 24-hour period. [ Time Frame: 24 h ] [ Designated as safety issue: No ]
  • Creatinine kinase myocardial fraction (CKMB) release over the perioperative 72-hour period [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Creatinine kinase myocardial fraction (CKMB) release over the perioperative 24-hour period [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Pro Brain natriuretic peptide (proBNP) release over the perioperative 72-hour period. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Aspartate aminotransferase (AST) release over the perioperative 72-hour period. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Alaninaminotransferas (ALAT) release over the perioperative 72-hour period. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Alkaline phosphatase (ALP) release over the perioperative 72-hour period. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Bilirubin release over the perioperative 72-hour period [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Creatinine release over the perioperative 72-hour period [ Time Frame: 72 h ] [ Designated as safety issue: No ]
  • Cystatin C release over the perioperative 72-hour period [ Time Frame: 72 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sodium nitrate
Preoperative oral administration of sodium nitrate. 700 mg the night before surgery and 700 mg three hours before surgery
 Dietary Supplement: Sodium nitrate
Preoperative oral administration of sodium nitrate. 700 mg the night before surgery and 700 mg three hours before surgery
Placebo Comparator: Placebo
Preoperative oral administration of sodium chloride the night before surgery and three hours before surgery
 Other: Sodium chloride
Preoperative oral administration of sodium chloride the night before surgery and three hours before surgery

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01348971

Contacts
Contact: Eddie T Weitzberg, MD, PhD +46 8 524 87994 eddie.weitzberg@ki.se

Locations
Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden, S-171 76
Principal Investigator: Anders Franco Cereceda, MD, PhD            
Principal Investigator: Jan Liska, MD, PhD            
Sub-Investigator: Fredrik Eidhagen, MD            
Principal Investigator: Jon Lundberg, MD,PhD            
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Eddie T Weitzberg, MD,PhD Karolinska Institutet
  More Information

No publications provided

Responsible Party: Eddie Weitzberg, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01348971     History of Changes
Other Study ID Numbers: KI-101
Study First Received: May 4, 2011
Last Updated: May 4, 2011
Health Authority: Sweden: Medical Products Agency

Keywords provided by Karolinska Institutet:
sodium nitrate
coronary artery bypass surgery
ischemia-reperfusion
myocardial injury

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013