Brain SPECT Following Cialis (Tadalafil ) Administration

NCT ID: NCT01374347

Last Updated: 2016-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Change in Brain Perfusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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One dose, Repeat doses

First group recives one dose Second group receives several doses

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wolfson Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mordechai Lorberboym Prof

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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0044-11 WOMC

Identifier Type: -

Identifier Source: org_study_id

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