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

Stopped early · Phase 2

Conditions studied: Right Ventricular Infarction

In brief

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

Key facts

Study ID

NCT00782652

Run by

Mallinckrodt

People needed

3

Starts

2006-03-01

Expected to finish

2007-02-01

Last updated by the study team

2016-09-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• University Hospital Gasthuisberg, University of Leuven — Leuven, Belgium
• Univeristy of Ottawa Heart Institute — Ottawa, Ontario, Canada
• Institute of Cardiology Warsaw — Alpejska, Poland
• Cardiovascular Department, Hospital Clinic — Barcelona, Spain

Full record on ClinicalTrials.gov

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