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Sponsored by: |
Soroka University Medical Center |
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Information provided by: | Soroka University Medical Center |
ClinicalTrials.gov Identifier: | NCT00337116 |
This is a randomized, double blind, placebo-controlled study, clinical trail designed to evaluate the efficacy safety and superiority of intravenous boluses of isosorbide dinitrate for the relief of acute anginal pain episodes in acute coronary syndrome patients in comparison with the usual manner of S/L isosorbide dinitrate .
Condition | Intervention | Phase |
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Unstable Angina Myocardial Infarction |
Drug: iso sorbide dinitrate iv bolus or s/l |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Intravenous Isosorbide Dinitrate Versus Sublingual Isosorbide Dinitrate for the Relief of Acute Anginal Episodes in Acute Coronary Syndrome (ACS) Patients |
Estimated Enrollment: | 80 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | January 2008 |
Analgesia is an important element in the management of ACS patients. Pain contributes to the heightened sympathetic activity that is particularly prominent during periods of acute STEMI, NSTEMI and unstable angina and consequentially causes elevation of tissue oxygen demand. Control of cardiac pain is typically accomplished with a combination of oxygen, analgesic (e.g. morphine) beta blockers agents and primarily nitrates.
Sublingual nitrates are currently the guidelines recommended preparation for instant relief of brief episodes of pain. In patients with prolonged periods of waxing and waning chest pain, drip of intravenous nitrates may be of benefit in controlling of symptoms and correcting ischemia.
Intravenous nitrates are also indicated for the treatment of acute decompensated CHF patients with pulmonary edema, nevertheless the current treatment for these patients edema is repeated intravenous boluses of and not sublingual isosorbide dinitrate, followed by continuous drip. Although there is no hard data on intravenous high-dose nitrates for the relief of acute anginal pain episodes, our clinical impression with this method is excellent.
Intravenous boluses of isosorbide dinitrate in a hospital setting provides immediate, accurate (bioavailability ) and is an easily controlled modality for providing nitrates.
Since intravenous boluses of isosorbide dinitrate is the standard care for acute anginal pain episodes in our ICCU at this time, a well designed comparative study for the two methods would help it to become a guideline and not a matter of choice in these cases.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Willing and able to provide written informed consent according to the regulations of the Ministry of Health and the Helsinki committee instructions.
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Exclusion Criteria:
Inability to comply with the protocol and follow-up
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Contact: DORON ZAHGER, PROF. | 97286403468 | dzahger@bgu.ac.il |
Contact: AVI SHIMONY, MD | 97286400418 | ashimony@bgu.ac.il |
Israel | |
Intensive Cardiac Care Unit | Recruiting |
beer sheva, Israel |
Principal Investigator: | doron zahger, prof | soroka university medical center israel |
Responsible Party: | SOROKA UNIVERSITY MEDICAL CENTER ( DORON ZAHGER ) |
Study ID Numbers: | sor435006ctil |
Study First Received: | June 14, 2006 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00337116 |
Health Authority: | Israel: Ministry of Health |
Isosorbide Heart Diseases Isosorbide-5-mononitrate Myocardial Ischemia Angina Pectoris Vascular Diseases Isosorbide Dinitrate Pain Ischemia |
Chest Pain Nitric Oxide Signs and Symptoms Necrosis Acute Coronary Syndrome Infarction Myocardial Infarction Angina, Unstable |
Vasodilator Agents Pathologic Processes Molecular Mechanisms of Pharmacological Action Natriuretic Agents Diuretics, Osmotic Therapeutic Uses |
Physiological Effects of Drugs Diuretics Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions Nitric Oxide Donors |