Concomitant Milrinone and Esmolol Treatment in Patients With Acute Myocardial Infarction
Status:
Withdrawn
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
Summary
Heart attack is the leading cause of death in the developed world. Following heart attack,
re-establishing blood flow in a clogged heart vessel using percutaneous coronary intervention
(PCI) is the standard of care. This therapy is called reperfusion therapy. Unfortunately,
reperfusion therapy itself poses additional heart muscle damaging effect, a process called
reperfusion injury. Excessive reperfusion injury can offset the net benefit of heart vessel
blood flow restoration in patients with heart attacks. For those heart attack survivors,
massive reperfusion injury can contribute to heart failure which carries high risk for death
and long-term disabilities. To date, there is no drug available that can reduce reperfusion
injury in heart attack patients.
Our group has demonstrated in a preclinical study that combining two available medications
(milrinone and esmolol) when given right before the onset of reperfusion therapy greatly
reduces heart muscle damage in an animal heart attack model. Furthermore, in a clinical
safety, we demonstrated that combination therapy with milrinone and esmolol is safe in
patients with heart attack undergoing PCI. If the heart-protective effect observed in our
preclinical study can be replicated in human subjects, this proposed therapy will become the
first of this kind to treat clinical reperfusion injury.
The present trial is a proof-of-concept study to determine whether the combination
administration of milrinone and esmolol at the onset of reperfusion reduces the heart muscle
damage in heart attack patients who receive reperfusion therapy with PCI.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Ming-He Huang
Collaborators:
Shantou University Medical College University of Texas