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

NCT ID: NCT00782652

Last Updated: 2016-09-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2007-02-28

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 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.

Conditions

Right Ventricular Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

inhaled nitric oxide at 40 or 80ppm

Group Type: ACTIVE_COMPARATOR

inhaled nitric oxide

Intervention Type: DRUG

Continuous delivery at either 40 or 80 ppm for a duration of up to 14 days

2

inhaled nitrogen at either 40 or 80ppm

Group Type: PLACEBO_COMPARATOR

nitrogen gas

Intervention Type: DRUG

Continuous delivery at either 40 or 80 ppm for a duration of up to 14 days

Interventions

inhaled nitric oxide

Continuous delivery at either 40 or 80 ppm for a duration of up to 14 days

Intervention Type: DRUG

nitrogen gas

Continuous delivery at either 40 or 80 ppm for a duration of up to 14 days

Intervention Type: DRUG

Other Intervention Names

INOmax

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mallinckrodt

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States; Belgium; Canada; Poland; Spain

Other Identifiers

INOT43

Identifier Type: -

Identifier Source: org_study_id