The Effects of Nitric Oxide for Inhalation in Right Ventricular Infarction Patients

• Status: Terminated
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to better understand the effects of nitric oxide, a gas for inhalation, on patients with right ventricular infarction.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mallinckrodt
• Treatments: Nitric Oxide

Criteria

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.