Randomised trial to evaluate the clinical value of intensive glucose monitoring and regulation in Acute Coronary Syndromes

Randomised trial to evaluate the clinical value of intensive glucose monitoring and regulation in Acute Coronary Syndromes - BIOMArCS Project II; Glucose regulation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON32341

Enrollment

300

Registered

2008-06-30

Start date

2008-07-23

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction in diabetes

Interventions

Intensive (48 hours IV insulin) vs. conventional (current expectative treatment)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Myocardial infarction and hyperglycemia

Exclusion criteria

Exclusion criteria: 1. A history of insulin dependent diabetes mellitus (note that patients with non-insulin dependent diabetes mellitus can be included). 2. Myocardial ischemia precipitated by a condition other than atherosclerotic coronary artery disease (e.g. arrhythmia, severe anemia, hypoxia, thyrotoxicosis, cocaine, severe valvular disease, hypotension). 3. Known severely-impaired left ventricular function (ejection fraction

Design outcomes

Primary

Measure	Time frame
Extend of myocardial damage expressed by Troponin T level at 72 hours.	—

Secondary

Measure	Time frame
Left Ventricle Ejection Fraction (LVEF) and infarct size at 6 weeks Extend of myocardial damage as expressed by area under CKMB curve. ST segment resolution after 6 hours Serum NTpro BNP values after 0 & 72 hours and 6 weeks Mortality and non fatal re-infarction HbA1C and fasting glucose values at 6 weeks. Biomarkers of (vascular) inflammation, hypercoagulability or neurohumoral activation at admission, 24, 48 and 72 hours and 6 weeks after randomization	—

Measure

Time frame

Left Ventricle Ejection Fraction (LVEF) and infarct size at 6 weeks Extend of myocardial damage as expressed by area under CKMB curve. ST segment resolution after 6 hours Serum NTpro BNP values after 0 & 72 hours and 6 weeks Mortality and non fatal re-infarction HbA1C and fasting glucose values at 6 weeks. Biomarkers of (vascular) inflammation, hypercoagulability or neurohumoral activation at admission, 24, 48 and 72 hours and 6 weeks after randomization

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)