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

This study is currently recruiting participants.
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
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Dietary Supplement: Bilberry extract
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bilberry as a Dietary Supplement After Myocardial Infarction (The BEAR SMART Trial)

Resource links provided by NLM:


Further study details as provided by University Hospital Orebro:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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,


Estimated Enrollment: 50
Study Start Date: February 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dietary supplement with bilberry extract
Billberry powder 3 times daily for 2 months.
Dietary Supplement: Bilberry extract

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01958034

Contacts
Contact: Ole Frobert, MD, PhD 46 19 602 54 13 ole.frobert@orebroll.se

Locations
Sweden
Department of Cardiology, Orebro University Hospital Recruiting
Orebro, Sweden, 70185
Contact: Ole Frobert, MD, PhD    46 19 602 54 13    ole.frobert@orebroll.se   
Principal Investigator: Ole Frobert, MD, PhD         
Sponsors and Collaborators
University Hospital Orebro
Investigators
Principal Investigator: Ole Frobert, MD, PhD Department of Cardiology, Orebro University Hospital, Sweden
  More Information

No publications provided

Responsible Party: Ole Frobert, MD, PhD, University Hospital Orebro
ClinicalTrials.gov Identifier: NCT01958034     History of Changes
Other Study ID Numbers: 2013-06-05
Study First Received: September 27, 2013
Last Updated: February 13, 2014
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 14, 2014