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Evaluation of Intracoronary Hyperoxemic Oxygen Therapy in Anterior Acute Myocardial Infarction Patients (IC-HOT) (IC-HOT Trial)
N/A
Waitlist Available
Led By Gregg W. Stone, MD
Research Sponsored by TherOx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
The primary objective of the study is to collect confirmatory data supporting the safety and effectiveness of SSO2 Therapy in treatment of anterior acute myocardial infarction (AMI) patients who have undergone successful percutaneous coronary intervention (PCI) with stenting within six hours of experiencing AMI symptoms.
Eligible Conditions
- Heart Attack
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Median Infarct Size by Cardiac MRI
Microvascular Obstruction by Cardiac MRI
Rate of Net Adverse Clinical Events (NACE)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: SSO2 TherapyExperimental Treatment1 Intervention
Delivery of SSO2 Therapy for 60 minutes selectively into the left main coronary artery (LMCA) using the TherOx DownStream System along with a single use disposable device called the TherOx DownStream Cartridge and a commercially available, qualified SSO2 delivery catheter
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SSO2 Therapy
2016
N/A
~100
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Who is running the clinical trial?
TherOxLead Sponsor
5 Previous Clinical Trials
1,757 Total Patients Enrolled
Gregg W. Stone, MDPrincipal InvestigatorColumbia University
3 Previous Clinical Trials
10,171 Total Patients Enrolled