Clinical trial NCT01958034: Bilberry as a Dietary Supplement After Myocardial Infarction (The BEAR SMART Trial)
Official title: Bilberry as a Dietary Supplement After Myocardial Infarction (The BEAR SMART Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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)

Primary outcomes:
measure: 6 minutes walk test
timeFrame: 2 months
Secondary outcomes:
measure: C-reactive protein
timeFrame: Baseline and 2 months
measure: Inflammatory markers and markers of heart function
timeFrame: Baseline and 2 months
Other outcomes:
Locations:
city: Orebro
country: Sweden
facility: Department of Cardiology, Orebro University Hospital
Study officials:
affiliation: Department of Cardiology, Orebro University Hospital, Sweden
name: Ole Frobert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arevstrom L, Bergh C, Landberg R, Wu H, Rodriguez-Mateos A, Waldenborg M, Magnuson A, Blanc S, Frobert O. Freeze-dried bilberry (Vaccinium myrtillus) dietary supplement improves walking distance and lipids after myocardial infarction: an open-label randomized clinical trial. Nutr Res. 2019 Feb;62:13-22. doi: 10.1016/j.nutres.2018.11.008. Epub 2018 Nov 17.