Patients scheduled for both heart catheterization and endomyocardial biopsy, with planned use of isosorbide dinitrate (ISDN) During the Procedure.
Conditions
Interventions
None listed
Sponsors
Oita University
Nagoya City University Department of Cardiology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients scheduled for both heart catheterization and endomyocardial biopsy Patients planned to have a sheath placed in the radial artery Patients expected to receive 1.0 mg or more of isosorbide dinitrate injection (5 mg/10 mL) during coronary angiography. Individuals aged 18 years or older and 85 years or younger at the time of consent Patients with a BMI (Body Mass Index) of 18.0 kg/m2 or higher and 35.0 kg/m2 or lower at screening. Patients who have provided written consent
Exclusion criteria
Exclusion criteria: AST and ALT levels exceeding three times the upper limit of normal values. Serum creatinine levels exceeding 1.5 times the upper limit of normal values. Requirement for continuous oxygen therapy due to pulmonary disease. Decompensated heart failure at the time of consent. Patients diagnosed with severe valvular disease by echocardiography. Deemed unsuitable for this study by the investigator. Exclusion Criteria for Lab Values Obtained During Cardiac Catheterization Cardiac Index (CI) obtained by the thermodilution method is 1.8 L/min/m2 or below. Pulmonary Artery Wedge Pressure (PAWP) is 18 mmHg or higher. Pulmonary Vascular Resistance (PVR) calculated as (mean PAP - PAWP) / CO is 3.0 Wood or higher, or mean PAP is 25 mmHg or higher. A sheath could not be placed in the radial artery. The physician deems the administration of Isosorbide Dinitrate inappropriate due to reasons such as hypotension.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insantaneous Extraction Ratio (ER) of Isosorbide Dinitrate in the lung. | — |
Countries
Japan
Contacts
Public ContactKosuke Hayashi
Oita University Department of Clinical Pharmacology and Therapeutics
Outcome results
None listed