Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00200629
Status:
TERMINATED
Last Update Posted:
2011-08-09
First Post:
2005-09-12
Brief Title:
Both Exercise and Adenosine Stress Testing
Sponsor:
Midwest Heart Foundation
Organization:
Midwest Heart Foundation
Study Overview
Official Title:
A Pilot Study Examining the Value of Combined Exercise and Adenosine Stress Myocardial Perfusion Imaging as Compared With Adenosine Testing Alone for the Evaluation of Women at Intermediate or High Likelihood for Coronary Artery Disease
Status:
TERMINATED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the 2-year cardiac outcomes for women with limited exercise capability based on the resuls of either pharmacological stress myocardial perfusion imaging or a combined protocol that incorporates both exercise and pharmacological stress The goal of the study is to compare these two methods for patient tolerability safety and prognostic value
Detailed Description:
Coronary artery disease remains the leading cause of morbidity and mortality in women accounting for more than 250000 deaths per year Despite the high prevalence in ischemic heart disease in women most clinical trials have focused on male cohorts The optimal non-invasive test for evaluation of ischemic heart disease in women is unknown A number of different modalities have been employed including exercise ECG stress testing 2-dimensional stress echocardiography SPECT myocardial perfusion imaging and electron beam computerized tomography
The cohort of women for whom to perform testing upon is also ill-defined Myocardial perfusion imaging in conjunction with pharmacologic stress testing has also been shown to be effective in the diagnosis of women with known or suspected coronary artery disease as well as in for risk stratification Recently pharmacologic stress has been combined with low-level exercise enhancing test tolerability and SPECT perfusion image quality Furthermore the use of a combined adenosine and exercise protocol may detect greater amounts of ischemia with perfusion imaging that with an exercise test alone Therefore in women who may be unable to perform maximal exercise this combined pharmacologic and exercise imaging protocol may possess a significant advantage over adenosine stress testing alone
The aim of this study is to compare safety and symptoms associated with these two methods of stress testing The current study also seeks to establish the optimal method for detection of coronary artery disease in women who have a limited capacity for exercise DASI score 5 METS also well as examine the prognostic value of each method of testing by comparing the two-year event rates for women who undergo adenosine SPECT imaging or SPECT imaging using adenosine with adjunctive exercise
The cohort of women for whom to perform testing upon is also ill-defined Myocardial perfusion imaging in conjunction with pharmacologic stress testing has also been shown to be effective in the diagnosis of women with known or suspected coronary artery disease as well as in for risk stratification Recently pharmacologic stress has been combined with low-level exercise enhancing test tolerability and SPECT perfusion image quality Furthermore the use of a combined adenosine and exercise protocol may detect greater amounts of ischemia with perfusion imaging that with an exercise test alone Therefore in women who may be unable to perform maximal exercise this combined pharmacologic and exercise imaging protocol may possess a significant advantage over adenosine stress testing alone
The aim of this study is to compare safety and symptoms associated with these two methods of stress testing The current study also seeks to establish the optimal method for detection of coronary artery disease in women who have a limited capacity for exercise DASI score 5 METS also well as examine the prognostic value of each method of testing by comparing the two-year event rates for women who undergo adenosine SPECT imaging or SPECT imaging using adenosine with adjunctive exercise
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None