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

Region Örebro County

Status and phase

Completed

Phase 4

Conditions

Myocardial Infarction

Treatments

Dietary Supplement: Bilberry extract

Study type

Interventional

Funder types

Other

Identifiers

NCT01958034

2013-06-05

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)