Brain SPECT Following Cialis (Tadalafil ) Administration (CIALIS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mordechai Lorberboym Prof, Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01374347
First received: June 14, 2011
Last updated: February 8, 2016
Last verified: February 2016
  Purpose
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.

Condition
Change in Brain Perfusion

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brain SPECT Perfusion Imaging Following Cialis (Tadalafil ) Administration in Patients With Vascular Risk Factors

Resource links provided by NLM:


Further study details as provided by Wolfson Medical Center:

Enrollment: 30
Study Start Date: May 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female patients in the age range of 35-75 years.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Mordechai Lorberboym Prof, PI, Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01374347     History of Changes
Other Study ID Numbers: 0044-11 WOMC 
Study First Received: June 14, 2011
Last Updated: February 8, 2016
Health Authority: Israel:Edith Wolfson Medical Center

Additional relevant MeSH terms:
Tadalafil
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on July 21, 2016