Brain SPECT Following Cialis (Tadalafil ) Administration (CIALIS)

Brain SPECT Perfusion Imaging Following Cialis (Tadalafil ) Administration in Patients With Vascular Risk Factors

The study will be an open label one and will include 30 patients who underwent ischemic stroke 3 month to 3 years prior to the study. All patients will undergone a baseline brain SPECT perfusion study. 15 patients will take one dose of 20 mg cialis, and will have a second brain SPECT 24 hours after cialis administration. 15 other patients (age and risk factor matched) will be prescribed 5 mg of cialis once daily for 7 days, and a second SPECT study will be performed 24 hours after the last dose.

Study Overview

• Status: Completed
• Conditions: Change in Brain Perfusion

• Study Type: Observational
• Enrollment (Actual): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male and female patients in the age range of 35-75 years.

Description

Inclusion Criteria:

• Male and female patients in the age range of 35-75 years.

Exclusion Criteria:

1. known allergic reaction to TF
2. Medical contraindication to use TF
3. Hemorrhagic stroke including intracerebral hemorrhage and subarachnoid hemorrhage
4. Acute stroke or cardiac ischemic event up to 3 month prior to study.
5. Other neurological brain diseases including degenerative diseases, multiple sclerosis, brain tumors, post severe brain injury (TBI) and migraine headache.
6. Sensory aphasia.
7. Cognitive impairment with disability to sign a consent form.Patients' Assessment

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
One dose, Repeat doses; First group recives one dose Second group receives several doses
One dose, several doses; 15 patients will take one dose of 20 mg cialis, and will have a second brain SPECT 24 hours after cialis administration. 15 other patients (age and risk factor matched) will be prescribed 5 mg of cialis once daily for 7 days, and a second SPECT study will be performed 24 hours after the last dose.

Collaborators and Investigators

• Sponsor: Wolfson Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (ACTUAL): July 1, 2012
• Study Completion (ACTUAL): July 1, 2012

Study Registration Dates

• First Submitted: June 14, 2011
• First Submitted That Met QC Criteria: June 14, 2011
• First Posted (ESTIMATE): June 15, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2016
• Last Update Submitted That Met QC Criteria: February 8, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 0044-11 WOMC