Stable AnginaNCT00719992
Diagnostic Value of HS-CRP in Stable Angina.
A study testing coronary angiography in people with Stable Angina and Positive ETT, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 43 to 64 years
- Conditions the study is for
- Stable Angina, Positive ETT
- What is being tested?
- coronary angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteIran
- Study dates
- Apr 2006to Aug 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 43 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Stable angina
- Positive ETT
Who cannot join
- Unability to perform ETT
- Contraindications for ETT and angiography study
Trial locations and contacts
1 site in 1 country.
Iran1 site
Cardiology Ward Shiraz University of Medical Sciences
Shiraz, Fars, 51318
About this study
Official title: Diagnostic Value of HS-CRP in Stable Angina Patients With Positive Exercise Test as Compared With Coronary Angiography.
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.
Read the 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.
- Conditions
- Stable Angina, Positive ETT
- Being tested
- coronary angiography
- Keywords
- Exercise tolerance test, HS-CRP, Coronary angiography, Patients
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary angiographyProcedure or surgery
effect of level of HS-CRP
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | positive ETT, High HS-CRP Receives: Procedure: coronary angiography |
| 2 | Active comparator | positive ETT, Low HS-CRP Receives: Procedure: coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
significant coronary lesion
Secondary outcomes (1)
severity of CAD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2008 (estimated)
- Study startApr 2006
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- javad kojuri, M.D., Study director, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719992
- Sponsor's protocol ID
- 4543
- Status last verified
- Jul 2008
- First submitted
- 18 Jul 2008
- Last updated
- 22 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of HS-CRP in Stable Angina Patients With Positive Exercise Test as Compared With Coronary Angiography.
- ClinicalTrials.gov ID
- NCT00719992
- Acronym / sponsor ID
- 4543
- Conditions
- Stable Angina, Positive ETT
- Keywords
- Exercise tolerance test, HS-CRP, Coronary angiography, Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 22 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: coronary angiographypositive ETT, High HS-CRP |
| 2 | Active comparator | Procedure: coronary angiographypositive ETT, Low HS-CRP |
Who may qualify
- Ages
- 43 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Stable angina
- Positive ETT
Key exclusion criteria (2 listed)
- Unability to perform ETT
- Contraindications for ETT and angiography study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coronary angiographyeffect of level of HS-CRP | Procedure or surgery | 1, 2 |
Primary outcome
significant coronary lesion
1 secondary outcome
severity of CAD
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
javad kojuri, M.D. study director
Shiraz University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coronary angiography in people with Stable Angina and Positive ETT, run by Shiraz University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
significant coronary lesion. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2008.