Status:
TERMINATED
The Effects of Nitric Oxide for Inhalation in Right Ventricular Infarction Patients
Lead Sponsor:
Mallinckrodt
Conditions:
Right Ventricular Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is designed to better understand the effects of nitric oxide, a gas for inhalation, on patients with right ventricular infarction.
Detailed Description
This is a prospective, randomized, double-blind, placebo-controlled study that will assess the feasibility of studying inhaled nitric oxide for the treatment of cardiogenic shock due to right ventricu...
Eligibility Criteria
Inclusion
- Acute inferior mycardial infarction (defined as an episode of chest pain lasting \>30 minutes and electrocardiographic evidence of 1 mm or greater ST elevation in inferior leads) within the past 72 hours.
- Invasive hemodynamic evidence of hemodynamically-significant RV dysfunction, defined as the presence of all the following: systemic venous congestion (mean RA pressure \> 10mmHg), the ratio of RA/PCW pressure 0.75 or greater, a low cardiac output as determined by Fick or Thermodilution (TD) technique (cardiac index \< 2.5 l/min/m2), systolic systemic arterial blood pressure of 90mmHg or less or requiring vasopressor or mechanical support to maintain systolic pressure \> 90mmHg. Patients with a PCWP of 14mmHg or less should receive intravascular volume repletion until their PCWP is \> 14mmHg.
- Coronary angiography revealing either an occlusion of the RCA proximal to any RV marginal branch or evidence of diminished flow to RV marginal branches of the RCA.
- If patient undergoes coronary revascularization, there must be evidence of unsuccessful right ventricular reperfusion (lack of restoration of TIMI grade III flow in the distal RCA and \> 1mm RV marginal branches) or evidence of hemodynamically significant RVI must persist for greater than 1 hour after successful revascularization.
- Age 18 years or greater
Exclusion
- PCW 25mmHg or greater or mechanical complications of myocardial infarction requiring surgical correction.
- Severe LV systolic dysfunction as determined by the principal investigator. Unprotected left main coronary stenosis \> 50%.
- Pulmonary infiltrates consistent with pulonary edema on chest X-ray (if chest X-ray is clinically indicated).
- Evidence of shock-related end-organ damage, including creatinine 3.0 or greater, metabolic acidosis (pH 7.1 or less) and not corrected by 100 ml NaHCO3 (1mEq/ml), disseminated intravascular coagulation, or clinical evidence of diffuse brain injury.
- Previous history of severe pericardial, congenital, or valvular heart disease.
- Refractory hemodynamically significant arrhythmia.
- Presence of pneumonia, adult respiratory distress syndrome, or sepsis.
- Prior history of pulmonary disease requiring chronic oxygen therapy.
- Pregnancy
- Use of investigational drugs or device within the 30 days prior to enrollment to the study.
- Uncontrolled active bleeding.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00782652
Start Date
March 1 2006
End Date
February 1 2007
Last Update
September 9 2016
Active Locations (6)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
3
University Hospital Gasthuisberg, University of Leuven
Leuven, Belgium, B-3000
4
Univeristy of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7