The Effects of Nitric Oxide for Inhalation in Right Ventricular Infarction Patients
The Effects of Nitric Oxide for Inhalation in Right Ventricular Infarction Patients
This study is designed to better understand the effects of nitric oxide, a gas for
 inhalation, on patients with right ventricular infarction.
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 ventricular infarction, and the dose response of the acute hemodynamic changes
 occurring with nitric oxide inhalation in these patients. Patients with evidence of right
 ventricular infarction and cardiogenic shock, and have angiographic evidence of impaired
 blood flow to the right ventricle, or if right ventricular coronary perfusion is unimpared,
 cardiac shock persists, will be eligible for enrollment. Patients will receive standard of
 care for their condition, and will also recieve either nitric oxide for inhalation or placebo
 for up to 14 days.
Inclusion Criteria:

 -  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 Criteria:

 -  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.