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

Study Overview
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Brief Summary
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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.

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

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Dietary Supplement: Bilberry extract


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary supplement with bilberry extract<br>Billberry powder 3 times daily for 2 months. | Dietary Supplement: Bilberry extract<br> <br> |
| No Intervention: Control<br>No dietary supplement with bilberry extract | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minutes walk test | The effect of intervention on a standardized physical challenge - the 6 minutes walk test | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein | The effect of intervention on the inflammatory marker CRPö | Baseline and 2 months | 
| Inflammatory markers and markers of heart function | 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, | Baseline and 2 months |