Focus of Study is STEMI
Conditions
Brief summary
This study explores the potential cardioprotective properties of danegaptide when administered to patients with ST-Segment elevation myocardial infarction.
Interventions
DRUGdanegaptide
DRUGPlacebo
Sponsors
Zealand Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * ST-segment elevation myocardial infarction * Acute onset of chest pain of \< 12 hours duration
Exclusion criteria
* Pregnancy * Known prior Myocardial Infarction in same area as present STEMI, known hypertrophic or dilated cardiomyopathy, or prior hospital admission for heart failure * Contraindication for cardiac MRI * Inability to understand information or provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial Salvage Index | 3 months | Myocardial Salvage Index as assessed by MRI and calculated as the difference between myocardial volume at risk and final infarct size in relation to myocardial volume at risk |
Secondary
| Measure | Time frame |
|---|---|
| Relative Infarct size, Absolute Infarct size, Left Ventricular Ejection Fraction (LVEF), microvascular obstruction and infarct haemorrhage as determined by MRI | 3 months |
| Degree of ST-resolution and fraction of patients with 70 % ST-resolution measured by ECG 60 minutes post Percutaneous Coronary Intervention procedure | 60 minutes |
| Major Clinical Adverse Events including cardiac death, new or worsening heart failure and re-admission for heart failure | 3 months |
Countries
Denmark
Outcome results
None listed