Study to Monitor the Effects of Androgen Suppression Treatment on the Heart (AST)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01230905|
Recruitment Status : Completed
First Posted : October 29, 2010
Last Update Posted : April 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: PET scan and ultrasound||Phase 4|
Treatment group: Prior to the initiation of AST, subjects will have a baseline N-13-ammonia PET scan and a brachial artery ultrasound at the University of Ottawa Heart Institute. Blood glucose and a lipid profile will be obtained. These tests will be repeated 6 - 9 months after starting AST.
Cancer control group: The same testing and intervals will be performed. Normals control group: Baseline testing will be done to establish a normal.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||181 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Does Androgen Suppression Treatment In Prostate Cancer Reduce Myocardial Blood Flow Reserve?|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
MPI nuclear scan
Nuclear MPI for CAD for prostate cancer subjects undergoing treatment and development of normal comparison.
Radiation: PET scan and ultrasound
Nuclear rest/stress testing of the heart using N-13-ammonia paired with brachial artery ultrasound
- myocardial flow reserve [ Time Frame: 6 - 9 months ]The change in global absolute MFR between baseline and follow up PET studies, at a patient level. MFR is defined as the ratio between regional blood flow with maximum vasodilation and baseline regional blood flow.
- Regional myocardial perfusion [ Time Frame: 6 - 9 months ]
The change in absolute MFR between baseline and follow up tests for the 3 major coronary territories. Territories with severe reduction in flow or no flow on baseline images will be censored from this analysis. Regional myocardial perfusion will be assessed semi-quantitatively by summed stress scores and summed difference scores in each of the PET scans in the treatment and control groups.
Two-dimensional scans and pulse measures will be taken of the brachial artery with flow-mediated vasodilatation expressed as a percent change in arterial diameter from resting diameter.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01230905
|University of Ottawa Heart Institute|
|Ottawa, Ontario, Canada, K1Y 4W7|
|Principal Investigator:||Terrence Ruddy, MD||Ottawa Heart Institute Research Corporation|