Overview

Concomitant Milrinone and Esmolol Treatment in Patients With Acute Myocardial Infarction

Status:
Withdrawn
Trial end date:
2017-12-01
Target enrollment:
0
Participant gender:
All
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
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ming-He Huang
Collaborators:
Shantou University Medical College
University of Texas
Treatments:
Esmolol
Milrinone
Criteria
Inclusion Criteria:

- Men and women, 18 years of age or older, who present within 12 hours after the onset
of chest pain, who has ST-segment elevation of more than 0.1 mV in two contiguous
leads, and for whom the clinical decision is made to treat with PCI will be eligible
for enrollment.

Exclusion Criteria:

- Patients with cardiac arrest, ventricular fibrillation, cardiogenic shock, previous
acute myocardial infarction will not included in the study. Patients with occlusion of
the left main will be excluded. Patients with baseline heart rate <50 beats/min and
systolic BP<90 mmHg and pregnant patients will excluded. Finally, patients who have
any disorder that is associated with immunologic dysfunction (e.g., cancer, lymphoma,
a positive serologic test for the human immunodeficiency virus, or hepatitis) more
recently than 6 months before presentation will be excluded.