Bilberry as a Dietary Supplement After Myocardial Infarction (The BEAR SMART Trial)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University Hospital Orebro
Sponsor:
Information provided by (Responsible Party):
Ole Frobert, University Hospital Orebro
ClinicalTrials.gov Identifier:
NCT01958034
First received: September 27, 2013
Last updated: February 13, 2014
Last verified: February 2014

September 27, 2013
February 13, 2014
February 2014
October 2014   (final data collection date for primary outcome measure)
6 minutes walk test [ Time Frame: 2 months ] [ Designated as safety issue: No ]
The effect of intervention on a standardized physical challenge - the 6 minutes walk test
6 minutes walk test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
The effect of intervention on a standardized physical challenge - the 6 minutes walk test
Complete list of historical versions of study NCT01958034 on ClinicalTrials.gov Archive Site
  • C-reactive protein [ Time Frame: Baseline and 2 months ] [ Designated as safety issue: No ]
    The effect of intervention on the inflammatory marker CRPö
  • Inflammatory markers and markers of heart function [ Time Frame: Baseline and 2 months ] [ Designated as safety issue: No ]
    The effect of intervention on markers of inflammation: IL-6 (interleukin 6), TNF-α (tumor necrosis factor α), INF-γ (interferon γ), markers of oxidative stress: oxidized LDL, carbonylated proteins, 2-OHDG, H2O2, hexanoyl L lysine, nitrogen oxide synthase (NOS), markers of myocardial damage and heart failure: BNP (brain natriuretic peptide) and troponin I, markers of endothelial function: VEGF (vascular endothelial growth factor), 8-isoprostane, E-selectin, measures of plasma lipids; total cholesterol, LDL-cholesterol, TGA (triacylglycerides), and measures of patient compliance and biological effect of bilberry supplementation: quercetin,
  • C-reactive protein [ Time Frame: 2 weeks and 3 months ] [ Designated as safety issue: No ]
    The effect of intervention on the inflammatory marker CRPö
  • Inflammatory markers and markers of heart function [ Time Frame: 2 weeks and 3 months ] [ Designated as safety issue: No ]
    The effect of intervention on markers of inflammation: IL-6 (interleukin 6), TNF-α (tumor necrosis factor α), INF-γ (interferon γ), markers of oxidative stress: oxidized LDL, carbonylated proteins, 2-OHDG, H2O2, hexanoyl L lysine, nitrogen oxide synthase (NOS), markers of myocardial damage and heart failure: BNP (brain natriuretic peptide) and troponin I, markers of endothelial function: VEGF (vascular endothelial growth factor), 8-isoprostane, E-selectin, measures of plasma lipids; total cholesterol, LDL-cholesterol, TGA (triacylglycerides), and measures of patient compliance and biological effect of bilberry supplementation: quercetin,
Not Provided
Not Provided
 
Bilberry as a Dietary Supplement After Myocardial Infarction (The BEAR SMART Trial)
Bilberry as a Dietary Supplement After Myocardial Infarction (The BEAR SMART Trial)

In a double blinded, randomized, clinical trial of patients suffering from STEMI (ST-segment elevation myocardial infarction) or non-STEMI (non-ST-segment elevation myocardial infarction)compare the effect of 3 months of dietary supplement with bilberry extract on a range of parameters with prognostic importance in cardiovascular disease: lipids, inflammation, oxidative stress and heart function.

Following inclusion of 8 individuals and as of February 12, 2014: Due to intolerance to "bilberry placebo powder" we have amended to the protocoll that the trial design is changed from blinded to open and that the bilberry arm of the trial carries on in an open design and that the control group will receive no dietary supplement.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Myocardial Infarction
Dietary Supplement: Bilberry extract
Experimental: Dietary supplement with bilberry extract
Billberry powder 3 times daily for 2 months.
Intervention: Dietary Supplement: Bilberry extract
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Not Provided
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with a diagnosis of STEMI as defined by chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission, time from onset of symptoms of less than 24 hours, and an ECG with new ST-segment elevation in two or more contiguous leads of ≥0.2 mV in leads V2-V3 and/or ≥0.1 mV in other leads or a probable new-onset left bundle branch block.
  • Patients with a diagnosis of non-STEMI as defined by a combination of; onset of symptoms such as central chest pain or an aggravated angina pectoris, with or without an ECG change with ST-segment lowering or an inverted T-wave, and at least two values with levels of troponin-T or troponin-I above the established margin of an MI.

Exclusion Criteria:

  • Need for emergency coronary artery bypass grafting
  • Inability to provide informed consent
  • Age below 18 years
  • Previous randomization in the BEAR SMART trial
  • A daily intake, or the intent to start a daily intake of bilberries in some form (fresh berries, bilberry powder, bilberrysoup etc)

Exclusion Criteria:

  • Need for emergency coronary artery bypass grafting
  • Inability to provide informed consent
  • Age below 18 years
  • Previous randomization in the BEAR SMART trial
  • A daily intake, or the intent to start a daily intake of bilberries in some form (fresh berries, bilberry powder, bilberrysoup etc)
Both
18 Years and older
No
Contact: Ole Frobert, MD, PhD 46 19 602 54 13 ole.frobert@orebroll.se
Sweden
 
NCT01958034
2013-06-05
No
Ole Frobert, University Hospital Orebro
University Hospital Orebro
Not Provided
Principal Investigator: Ole Frobert, MD, PhD Department of Cardiology, Orebro University Hospital, Sweden
University Hospital Orebro
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP