Safety of TG100-115 for Heart Attack Treated With Angioplasty (NCT00103350) | Clinical Trial Compass
CompletedPhase 1/2
Safety of TG100-115 for Heart Attack Treated With Angioplasty
United States100 participantsStarted 2005-01
Plain-language summary
TG100-115 is able to reduce the size of heart attacks in pre-clinical models. The hypothesis of this study is that TG100-115 can be given safely to patients who suffer a heart attack and undergo angioplasty to restore blood flow. We will also evaluate whether TG100-115 reduces heart muscle damage.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-80 yrs
* ECG patterns consistent with an acute anterior myocardial infarction with ST segment elevation of 2mm in two contiguous ECG leads among leads V1-V4.
* Have prolonged, continuous (lasting at least 20 mins) signs and symptoms of myocardial ischemia not eliminated with nitrates.
* Intent to proceed to primary PCI within 6 hours of chest pain onset
* Sign an informed consent form and be willing to attend follow-up visits for safety and other study assessments.
Exclusion Criteria:
* Female of childbearing potential.
* History of previous myocardial infarction.
* History of congestive heart failure.
* Requirement for a cardiac pacemaker or defibrillator.
* Cardiogenic shock.
* Patients previously treated with thrombolytic therapy.
* Myocardial ischemia precipitated by a condition other than atherosclerotic coronary artery disease.