Brain SPECT Following Cialis (Tadalafil ) Administration (CIALIS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Wolfson Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01374347
First received: June 14, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted

June 14, 2011
June 14, 2011
July 2011
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No Changes Posted
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Brain SPECT Following Cialis (Tadalafil ) Administration
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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

Change in Brain Perfusion
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  • 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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
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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
Both
35 Years to 80 Years
No
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NCT01374347
0044-11 WOMC
No
Mordechai Lorberboym, M.D., Edith Wolfson Medical Center
Wolfson Medical Center
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Wolfson Medical Center
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP