Diagnostic Value of HS-CRP in Stable Angina.
Primary Purpose
Stable Angina, Positive ETT
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
coronary angiography
Sponsored by
About this trial
This is an interventional diagnostic trial for Stable Angina focused on measuring Exercise tolerance test, HS-CRP, Coronary angiography, Patients
Eligibility Criteria
Inclusion Criteria:
- Stable angina
- Positive ETT
Exclusion Criteria:
- Unability to perform ETT
- Contraindications for ETT and angiography study
Sites / Locations
- Cardiology Ward Shiraz University of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
positive ETT, High HS-CRP
positive ETT, Low HS-CRP
Outcomes
Primary Outcome Measures
significant coronary lesion
Secondary Outcome Measures
severity of CAD
Full Information
NCT ID
NCT00719992
First Posted
July 18, 2008
Last Updated
July 18, 2008
Sponsor
Shiraz University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00719992
Brief Title
Diagnostic Value of HS-CRP in Stable Angina.
Official Title
Diagnostic Value of HS-CRP in Stable Angina Patients With Positive Exercise Test as Compared With Coronary Angiography.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Shiraz University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study was to assess the amount of additive value of HS-CRP levels to a positive exercise tolerance test (ETT) in predicting coronary artery disease (CAD) using coronary angiography as the gold standard. The investigators concluded that HS-CRP can be used as a single predictor of coronary vessel involvement in patients with stable angina and positive ETT.
Detailed Description
the investigators included 97 patients with positive ETT and stable angina and saw that Hs-CRP is the only predictor of severity of CAD as compared with coronary angiography in stable angina patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina, Positive ETT
Keywords
Exercise tolerance test, HS-CRP, Coronary angiography, Patients
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
positive ETT, High HS-CRP
Arm Title
2
Arm Type
Active Comparator
Arm Description
positive ETT, Low HS-CRP
Intervention Type
Procedure
Intervention Name(s)
coronary angiography
Intervention Description
effect of level of HS-CRP
Primary Outcome Measure Information:
Title
significant coronary lesion
Secondary Outcome Measure Information:
Title
severity of CAD
10. Eligibility
Sex
All
Minimum Age & Unit of Time
43 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stable angina
Positive ETT
Exclusion Criteria:
Unability to perform ETT
Contraindications for ETT and angiography study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
javad kojuri, M.D.
Organizational Affiliation
Shiraz University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Cardiology Ward Shiraz University of Medical Sciences
City
Shiraz
State/Province
Fars
ZIP/Postal Code
51318
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Diagnostic Value of HS-CRP in Stable Angina.
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