Overview
The Effects of Nitric Oxide for Inhalation in Right Ventricular Infarction Patients
Status:
Terminated
Terminated
Trial end date:
2007-02-01
2007-02-01
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
MallinckrodtTreatments:
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.