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

Myocardial Infarction Clinical Trial

— BEAR SMART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01958034
• Other study ID #: 2013-06-05
• Status: Completed
• Phase: Phase 4
• First received: September 27, 2013
• Last updated: October 9, 2016
• Start date: February 2014
• Est. completion date: November 2015

Study information

• Verified date: October 2016
• Source: Region Örebro County
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Dietary Supplement:
• Bilberry extract

Locations

Country	Name	City	State
Sweden	Department of Cardiology, Orebro University Hospital	Orebro

Sponsors (1)

Lead Sponsor	Collaborator
Region Örebro County

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 minutes walk test	The effect of intervention on a standardized physical challenge - the 6 minutes walk test	2 months	No
Secondary	C-reactive protein	The effect of intervention on the inflammatory marker CRPö	Baseline and 2 months	No
Secondary	Inflammatory markers and markers of heart function	The effect of intervention on markers of inflammation: IL-6 (interleukin 6), TNF-a (tumor necrosis factor a), INF-? (interferon ?), 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	No