Stable Angina PectorisNCT00281346
Non-invasive Diagnosis of Coronary Artery Stenoses by Doppler Echocardiography
A study testing Doppler echocardiography in people with Stable Angina Pectoris and Unstable Angina Pectoris, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Non-invasive evaluation of patients with stable angina and unstable coronary syndromes with transthoracic Doppler echocardiography to evaluate presence of significant coronary stenoses. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stable Angina Pectoris, Unstable Angina Pectoris, Acute Myocardial Infarction
- What is being tested?
- Doppler echocardiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2005to Aug 2008
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unstable angina or acute myocardial infarction, or stable angina pectoris and
- scheduled for coronary angiography on accepted clinical reasons
Who cannot join
- past coronary artery grafting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Evaluation of Coronary Pathology by Transthoracic Doppler Echocardiography. A Comparative Study to Coronary Angiography.
Non-invasive evaluation of patients with stable angina and unstable coronary syndromes with transthoracic Doppler echocardiography to evaluate presence of significant coronary stenoses. Blinded evaluation and comparison with coronary angiography: presence and location of stenoses, and head to head comparison of clinical value and patient classification.
Read the detailed description
Transthoracic Doppler echocardiographic evaluation with extensive evaluation of coronary stenoses in all 3 main branches using colour flow, pulsed Doppler and Coronary flow velocity reserve (CFVR)after pharmacologic stress with adenosin in the area of LAD and RDP. Blinded evaluation of Doppler results and coronary angiography regarding the other examination modality. Coronary angiography diagnostic "gold standard". Only stable and unstable patients otherwise scheduled for angiography on clinical reasons will be examined and included in the study.
Added January 2007 after ethics committee approval: comparison of CFVR with invasive fractional flow reserve (FFR) in selected subset of patients.
- Being tested
- Doppler echocardiography
- Keywords
- Doppler echocardiography, coronary stenosis, Coronary angiography
- Medical subject headings
- Angina, Stable, Angina, Unstable, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler echocardiographyProcedure or surgery
Echocardiography
| Study group | Role | What they receive |
|---|---|---|
| transthoracic Doppler echocardiography | Experimental | Not described Receives: Procedure: Doppler echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield: Accuracy, positive and negative predictive value.
Measured: Inhospital
pr patient evaluation
Measured: Inhospital
Secondary outcomes (1)
pr stenosis evaluation
Measured: Inhospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2006 (estimated)
- Study startDec 2005
- Primary completionJan 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stable Angina PectorisStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Torstein L Hole, MD, PhD, Study chair, Norwegian University of Science and TechnologyJohnny Å Vegsundvåg, MD, Principal investigatorRune Wiseth, MD, PhD, Study chair, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00281346
- Sponsor's protocol ID
- 29 FU-71-05
- Status last verified
- Jul 2016
- First submitted
- 23 Jan 2006
- Last updated
- 18 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Holte E, Vegsundvag J, Hegbom K, Hole T, Wiseth R. Transthoracic Doppler for detection of stenoses in the three main coronary arteries by use of stenotic to prestenotic velocity ratio and aliased coronary flow. Eur Heart J Cardiovasc Imaging. 2015 Dec;16(12):1323-30. doi: 10.1093/ehjci/jev158. Epub 2015 Jun 25.
PubMed 26113119Vegsundvag J, Holte E, Wiseth R, Hegbom K, Hole T. Coronary artery occlusions diagnosed by transthoracic Doppler. Cardiovasc Ultrasound. 2014 Mar 15;12:12. doi: 10.1186/1476-7120-12-12.
PubMed 24628779Vegsundvag J, Holte E, Wiseth R, Hegbom K, Hole T. Coronary flow velocity reserve in the three main coronary arteries assessed with transthoracic Doppler: a comparative study with quantitative coronary angiography. J Am Soc Echocardiogr. 2011 Jul;24(7):758-67. doi: 10.1016/j.echo.2011.03.010. Epub 2011 Apr 23.
PubMed 21524564Vegsundvag J, Holte E, Wiseth R, Hegbom K, Hole T. Transthoracic echocardiography for imaging of the different coronary artery segments: a feasibility study. Cardiovasc Ultrasound. 2009 Dec 22;7:58. doi: 10.1186/1476-7120-7-58.
PubMed 20028530
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Evaluation of Coronary Pathology by Transthoracic Doppler Echocardiography. A Comparative Study to Coronary Angiography.
- ClinicalTrials.gov ID
- NCT00281346
- Acronym / sponsor ID
- 29 FU-71-05
- Keywords
- Doppler echocardiography, coronary stenosis, Coronary angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 24 Jan 2006 (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.
Non-invasive evaluation of patients with stable angina and unstable coronary syndromes with transthoracic Doppler echocardiography to evaluate presence of significant coronary stenoses. Blinded evaluation and comparison with coronary angiography: presence and location of stenoses, and head to head comparison of clinical value and patient classification.
Detailed description
Transthoracic Doppler echocardiographic evaluation with extensive evaluation of coronary stenoses in all 3 main branches using colour flow, pulsed Doppler and Coronary flow velocity reserve (CFVR)after pharmacologic stress with adenosin in the area of LAD and RDP. Blinded evaluation of Doppler results and coronary angiography regarding the other examination modality. Coronary angiography diagnostic "gold standard". Only stable and unstable patients otherwise scheduled for angiography on clinical reasons will be examined and included in the study.
Added January 2007 after ethics committee approval: comparison of CFVR with invasive fractional flow reserve (FFR) in selected subset of patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transthoracic Doppler echocardiography | Experimental | Procedure: Doppler echocardiography |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- unstable angina or acute myocardial infarction, or stable angina pectoris and
- scheduled for coronary angiography on accepted clinical reasons
Key exclusion criteria (1 listed)
- past coronary artery grafting
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 |
|---|---|---|
| Doppler echocardiographyEchocardiography | Procedure or surgery | transthoracic Doppler echocardiography |
Primary outcome
Diagnostic yield: Accuracy, positive and negative predictive value.
Time frame: Inhospital
pr patient evaluation
Time frame: Inhospital
1 secondary outcome
pr stenosis evaluation
Time frame: Inhospital
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 18 Jul 2016.
- Results publication: PubMed 26113119Holte E, Vegsundvag J, Hegbom K, Hole T, Wiseth R. Transthoracic Doppler for detection of stenoses in the three main coronary arteries by use of stenotic to prestenotic velocity ratio and aliased coronary flow. Eur Heart J Cardiovasc Imaging. 2015 Dec;16(12):1323-30. doi: 10.1093/ehjci/jev158. Epub 2015 Jun 25.
- Derived from this study: PubMed 24628779Vegsundvag J, Holte E, Wiseth R, Hegbom K, Hole T. Coronary artery occlusions diagnosed by transthoracic Doppler. Cardiovasc Ultrasound. 2014 Mar 15;12:12. doi: 10.1186/1476-7120-12-12.
- Derived from this study: PubMed 21524564Vegsundvag J, Holte E, Wiseth R, Hegbom K, Hole T. Coronary flow velocity reserve in the three main coronary arteries assessed with transthoracic Doppler: a comparative study with quantitative coronary angiography. J Am Soc Echocardiogr. 2011 Jul;24(7):758-67. doi: 10.1016/j.echo.2011.03.010. Epub 2011 Apr 23.
- Derived from this study: PubMed 20028530Vegsundvag J, Holte E, Wiseth R, Hegbom K, Hole T. Transthoracic echocardiography for imaging of the different coronary artery segments: a feasibility study. Cardiovasc Ultrasound. 2009 Dec 22;7:58. doi: 10.1186/1476-7120-7-58.
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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.
Torstein L Hole, MD, PhD study chair
Norwegian University of Science and Technology
Johnny Å Vegsundvåg, MD principal investigator
Rune Wiseth, MD, PhD study chair
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doppler echocardiography in people with Stable Angina Pectoris and Unstable Angina Pectoris, run by Norwegian University of Science and Technology at 1 site in Norway.
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 1 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 18 Jul 2016. 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 Norway. 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?
Diagnostic yield: Accuracy, positive and negative predictive value. (time frame: Inhospital). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00281346, which also lists 4 linked publications.
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 18 Jul 2016.