Right Ventricular Infarction Clinical Trial
Official title:
The Effects of Nitric Oxide for Inhalation on Survival or the Need for Dialysis or a Right Ventricular Assistance Device (RVAD) 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.
| Status | Terminated |
| Enrollment | 3 |
| Est. completion date | February 2007 |
| Est. primary completion date | February 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | University Hospital Gasthuisberg, University of Leuven | Leuven | |
| Canada | Univeristy of Ottawa Heart Institute | Ottawa | Ontario |
| Poland | Institute of Cardiology Warsaw | Alpejska | |
| Spain | Cardiovascular Department, Hospital Clinic | Barcelona | |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | William Beaumont Hospital | Royal Oak | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Mallinckrodt |
United States, Belgium, Canada, Poland, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | survival to hospital discharge or Day 30, whichever occurs first without the need for renal replacement therapy or a Right Ventricular Assistance Device (RVAD) | hospital discharge or Day 30 | No | |
| Secondary | survival at 1 year after initial hospitalization | 1 year post treatment | No | |
| Secondary | time on vasoconstrictor or inotropic medications | study duration | Yes | |
| Secondary | duration of intraaortic balloon pump support, if applicable | study duration | Yes | |
| Secondary | time in intensive care unit | study duration | Yes | |
| Secondary | duration or need for mechanical ventilation | study duration | Yes | |
| Secondary | change in cardiac index by dose | baseline, hour 8, days 3 & 7, and at day 30 or discharge | Yes | |
| Secondary | change in right ventricule function and size by dose | baseline, hour 8, days 3 & 7 and at day 30 or discharge | Yes | |
| Secondary | change in pulmonary vascular resistance by dose | study duration | Yes | |
| Secondary | change in any right-to-left intracardiac shunt flow, as assessed by contrast echocardiography | study duration | Yes | |
| Secondary | neurohormonal assessment of prognosis with BNP, NT-pro BNP | Baseline, hour 8 and days 3 & 7 | Yes | |
| Secondary | incidence of mortality | treatment duration through 1 year | Yes | |
| Secondary | incidence and types of reported adverse events | study duration through day 30 or discharge | Yes |