Nimodipine for Treating Acute Massive Cerebral Infarction

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Massive cerebral infarction is an ischemic stroke caused by complete blockage of the internal carotid artery, middle cerebral artery, or their cortical branches. The widespread infarction, pathological severity and high fatality rate associated with massive cerebral infarction pose a major threat to affected patients. However, there is a lack of unified diagnostic criteria. Many researchers use Adams' classification, in which massive cerebral infarction is diagnosed when the following criteria are met: infarct size > 13 cm2; a major brain-feeding artery is involved; the focal site affects more than two cerebral lobes; infarct diameter line ≥ 3 cm in internal capsule of striatum.

Prolonged cerebral ischemia/reperfusion can induce complex secondary changes in brain tissue, so the use of neuroprotective agents is very important. Remarkable progress has been made over the last decade in understanding the protective effect of calcium antagonists against cerebral ischemia. In particular, the liposoluble dihydropyridine Ca2+ antagonist nimodipine selectively acts on cerebral vessels and neurons and can protect ischemic brain tissue, providing a new way of treating ischemic cerebrovascular disease.

Preclinical and clinical tests have shown that nimodipine has a protective effect on ischemic brain tissue, and indicate that patients should take the drug as soon as possible. However, there are no reports of double-blind, randomized, controlled clinical trials addressing the administration of nimodipine via intravenous drip within the time window for successful treatment of acute massive cerebral infarction.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fengtian Hospital
• Treatments: Cytidine Diphosphate Choline; Nimodipine

Criteria

Inclusion Criteria:

• First onset at age ≤ 80 years, no other severe medical complications;

• Clear consciousness or mild disturbance of consciousness; paralysis of upper and lower extremities on one side with grade 0-3 muscle strength in paralyzed limbs;

• CT reveals early massive cerebral infarction (without cerebral hemorrhage or old infarction);

• Blood pressure within, or higher than, the normal range.

Exclusion Criteria:

• Clinical manifestations are noticeably improved before treatment;

• Disorders of consciousness, manifesting as severe lethargy or coma;

• Mild neurological deficits, such as pure sensory disturbances, ataxia, dysarthria, and hemiparesis;

• Severe hypotension (systolic pressure < 90 mmHg, diastolic pressure < 60 mmHg);

• Heart rate < 60 BPM; sinus bradycardia;

• Severe heart, brain or kidney dysfunction, or malignant tumor.