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Home > "E" Clinical Trials Conditions > Effect of ProliNO on Brain Artery Spasms After Aneurysm Rupture  Effect of ProliNO on Brain Artery Spasms After Aneurysm Rupture
Effect of ProliNO on Brain Artery Spasms After Aneurysm Rupture
For Condition: Intracranial Vasospasm
Status: Recruiting
Sponsor(s): National Institute of Neurological Disorders and Stroke (NINDS) ,
Synopsis: This study will examine the effects of a drug called ProliNO on brain artery spasms (narrowing of the arteries) caused by bleeding in the subarachnoid space following rupture of a brain aneurysm. The subarachnoid is the space between the second and third layers of the meninges-connective tissue membrane surrounding the brain. An aneurysm is abnormal ballooning of a blood vessel. About half of patients with a ruptured brain aneurysm develop arterial spasms, with about 15 percent resulting in stroke or death. No available treatment consistently prevents or reverses these spasms. ProliNO, developed at the NIH, is an experimental drug that delivers the compound nitric oxide (NO) to arteries. NO dilates blood vessels and has reversed and prevented brain artery spasms in animals. This is the first study of the drug in humans. Patients 18 years of age and older admitted to INOVA Fairfax Hospital in Falls Church, Va., for treatment of a ruptured brain aneurysm may be eligible for this study. Candidates will be screened with a medical history and physical examination upon admission. Participants will undergo the following procedures: - Neurological assessment and physical examination: These examinations are done to evaluate the patient's ability to tolerate infusion of ProliNO during their coronary cerebral arteriogram procedure (see below). - Blood tests, urinalysis, chest x-rays and electrocardiogram (EKG): These tests are done upon admission to the hospital, before infusion of ProliNO, and after the arteriogram. - Cerebral arteriogram: This procedure is standard care for diagnosing and managing arterial spasm. Infusion of ProliNO during the procedure is experimental. An arteriogram is a diagnostic test that produces detailed x-ray images of the brain blood vessels, revealing any arterial spasms. The patient is sedated or asleep during the procedure. A needle is inserted into an artery (usually in the groin) and a catheter (long, flexible tube) is inserted through the needle into the artery. The catheter is threaded through the artery to the brain blood vessels. A dye is injected into the catheter, and x-ray pictures are taken to detect narrowing in the arteries. If vessel spasms are found, four injections of ProliNO are given at increasing doses, with each dose followed by another dye injection to see if the drug has opened the vessel. If possible, all four doses will be given even if the vessel is dilated before the last dose, in order to obtain safety information at the different doses. Heart rate, blood pressure, and breathing are monitored during the procedure, and blood samples are drawn from the catheter before ProliNO infusion and 1 hour after the infusion to measure drug levels and blood chemistries. When the procedure is completed, the patient's neurological status and blood pressure are monitored in the intensive care unit for 24 hours. - Head CT scan: Patients have a CT scan of the brain 24 to 48 hours after the cerebral arteriogram and ProliNO infusions. Patients will be re-evaluated with a physical examination and blood tests at NIH 1 month after the cerebral arteriogram. For patients who cannot return to NIH for this visit, an effort will be made to arrange the examination and blood test locally.
Details: Subarachnoid hemorrhage (SAH) due to the rupture of intracranial aneurysms affects almost 28,000 Americans annually. Almost 70% of patients with aneurysmal SAH develop severe spasm of the cerebral arteries. Despite aggressive medical therapy, neurological deficits resulting from vasospasm continue to be a major cause of morbidity and mortality. Endovascular techniques, such as transluminal cerebral angioplasty and infusion of intra-arterial papaverine, have been used as an adjunct to current medical management in an attempt to treat resistant spasm. However, the significant procedural risks and questionable success of these procedures in improvement of clinical outcome have prompted researchers to explore other therapeutic options. Although the etiology of cerebral vasospasm is poorly understood, there is increasing evidence that the decreased availability of nitric oxide (NO), a potent vasodilator, plays a significant role. Reversal of vasospasm by NO or NO prodrugs has been documented in several animal models. In our laboratory, ProliNO, a NO-donating compound, has been shown to safely reverse and prevent cerebral vasospasm after short and long-term intracarotid infusions in primates with no neurologic or systemic toxicity. Because of its extremely short half-life the vasodilatory effects of ProliNO with intracarotid delivery were limited to the cerebral vasculature. We hypothesize that ProliNO can be used safely and effectively to reverse vasospasm in symptomatic SAH patients. We propose to administer ProliNO intra-arterially in patients with aneurysmal SAH who are undergoing cerebral arteriography for vasospasm to determine the dose-limiting toxicity of transient intracarotid ProliNO administration and to determine if intracarotid administration of ProliNO has anti-vasospastic activity. This research protocol and the consent form will be presented to the patient after the treatment of a ruptured aneurysm if the patient is at a high risk for developing vasospasm. Patients admitted to the INOVA Fairfax Hospital Center with aneurysmal SAH and who will undergo cerebral arteriography for clinically significant cerebral vasospasm during their hospital course after their aneurysm is treated are eligible for this study. Thus, to participate in the trial, patients must be diagnosed with arteriographically demonstrated vasospasm. Since because of suspected vasospasm these patients are already undergoing cerebral arteriography there should be no added arteriography risks for patients in this trial. ProliNO will be injected into the internal carotid artery on the side of the affected vasculature via a microcatheter. Four increasing dosages of ProliNO will be infused and hemodynamic parameters will be monitored to assess any systemic effects. Any episode of significant (greater than 15 mmHg) and/or persistent (greater than 3 minutes) hypotension will immediately terminate the patient's participation in the study. Injections of contrast after each ProliNO infusion will be performed to evaluate any effects of ProliNO on the spastic vessels. Pre- and post-ProliNO infusion arteriograpic images will be used to compare vessel measurements. A detailed neurological examination will be documented immediately after all endovascular procedures are completed. The determination of the safety of intracarotid administration of ProliNO and its capacity to reverse vasospasm may enhance development of pharmacological treatment of cerebral vasospasm. However, no general or specific benefit to the patients participating in this study is expected.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients admitted to INOVA Fairfax Hospital with aneurysmal SAH who will undergo cerebral arteriography for clinically significant cerebral vasospasm during their hospital course are eligible for this study. Each patient will be admitted and treated for aneurysm rupture according to the standard care INOVA clinical treatment consent that is signed by the patient at the admission to the hospital. The consent for this research protocol will be presented to selected patients with a high risk of vasospasm (Fisher's grade 3 on CT) after the aneurysm is treated. The patient must be competent at the time consent is obtained. The protocol and the consent also will be presented to the patient's representative; so, if the patient becomes incapacitated by delayed vasospasm his/her representative will have the information necessary to make decisions related to the procedures described in the research protocol. The protocol and consent will be presented to the patient, by an investigator who will not perform the arteriography. To participate in the trial, patients must be diagnosed with arteriographically demonstrated vasospasm (regardless of whether their aneurysm(s) has been treated surgically or by endovascular techniques) and meet the following criteria: 1. Consenting males and females age 18 years old or older. 2. Written informed consent provided prior to participation in the study. Due to a significant risk that the patient who will sign the consent for a research protocol will become obtunded at the time of vasospasm, he/she will be also asked to designate a DPA who, if necessary, will make the decision whether or not to concur with the research consent. EXCLUSION CRITERIA: Patients will be excluded from the study if they meet any of the following criteria: 1. Hemodynamically unstable condition (SBP less than 90, DBP less than 70) 2. Pregnancy 3. Acute infection 4. Renal disorders: (Cr greater than 2 mg/dl, BUN greater than 35 mg/dl) 5. Coagulopathy: PT/PTT greater than 30 percent, platelets less than 80,000 6. Cardiac arrhythmias 7. Pulmonary edema 8. Hyponatremia if Na+ less than115 mEg/L
Total Enrollment: 80
Location and Contact Information:
National Institute of Neurological Disorders and Stroke (NINDS) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 030154; 03-N-0154
Study Start Date: April 10, 2003
Record last reviewed: March 30, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00059176
Other Intracranial Vasospasm Studies:
1. Effect of ProliNO on Brain Artery Spasms After Aneurysm Rupture
Related Studies:
Other Intracranial Vasospasm Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Effect of ProliNO on Brain Artery Spasms After Aneurysm Rupture
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