Coronary VesselsPhase 1NCT00427232
Endothelin-Receptor Blockade in Coronary Heart Disease
A Phase 1 study testing BQ-123 and BQ-788 in people with Coronary Vessels and Endothelins, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Endothelin is a hormon that causes acute and chronic narrowing of heart vessels. The purpose of this study is to assess whether suppression of this activity by using two types of receptor antagonists can reduce this effect and thus improve blood supply of the heart muscle. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Vessels, Endothelins, Vascular Resistance
- What is being tested?
- BQ-123 and BQ-788
- How many people
- 26 participants
- Where
- 1 siteAustria
- Study dates
- May 2003to Aug 2006
- Phase
- Phase 1
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- coronary artey disease
- stable angina pectoris
- male and post-menopausal female patients
- age above 19 years
- able and willing to conform to the requirements of the study
- provided written informed consent
Who cannot join
- severe focal coronary stenosis
- visually calcified stenosis
- aorto-ostial lesion location and unprotected left main stenosis
- pre-menopausal female patients
- diabetes mellitus
- unstable angina pectoris and/or acute Q-wave myocardial infarctaion within the past 72 hours
Show all 17Show fewer
- current vasoactive medication
- previous percutaneous transluminal revascularization at the site of the target lesion
- lesion which has extremely angulated segments >90%
- vessel with escessive tortuosity of the proximal segment
- severe hypotension
- severely reduced left ventricular function
- severe carotid stenosis
- patients with pace maker
- patients with elevated liver enzymes
- patients simultaneously participating in another device or drug study
- inability of unwillingness to comply with the study protocol
Trial locations and contacts
1 site in 1 country.
Austria1 site
Dept. of Internal Medicine II, Medical University of Vienna
Vienna, State of Vienna, A-1090
About this study
Official title: Selective and Non-Selective Endothelin-Receptor Blockade in Coronary Artey Disease
Endothelin is a hormon that causes acute and chronic narrowing of heart vessels. The purpose of this study is to assess whether suppression of this activity by using two types of receptor antagonists can reduce this effect and thus improve blood supply of the heart muscle.
Read the detailed description
Endothelin (ET) is the most potent vasoconstrictor known and plays a major role in the development of coronary artery disease as well as in acute vasoconstriction. This effect is mainly mediated by the vascular ET-A receptor, whereas the ET-B receptor mediates vasodilation and cleavage of ET. Currently, there are both selective ET-A antagonists and non-selective ET-A and ET-B antagonists under investigation. The aim of the study is to test the effect of ET-receptor blockade on the vasoreagibility of epicardial and intramyocardial coronary arteries in patients undergoing cardiac catheterization. We randomly use the selective ET-A receptor BQ-123 (Group A) and the combination of BQ-123 and the ET-B receptor antagonist BQ-788 (Group B). The tested infusion will be applied selectively into the assessed coronary artery by a special infusion catheter. To evaluate the morphometric changes we use quantitative coronary angiography to measure the diameter of the coronary artery before and after intracoronary infusion of the tested substances. Furthermore we will use Pressure Wire to measure the hemodynamic conditions before and after infusion, thus evaluating the epicardial and the intramyocardial blood perfusion.
Comparison: Coronary artery diameter as measured by quantitative angiography (minimal lumen diameter) and parameters indicative of epicardial and intramyocardial blood flow as determined by Pressure Wire (fractional flow reserver, coronary flow reserve, intramyocardial resistance) before and after ET-antagonist infusion will be compared.
- Conditions
- Coronary Vessels, Endothelins, Vascular Resistance
- Being tested
- BQ-123 and BQ-788
- Keywords
- coronary heart disease, endothelins, coronary angiography, blood flow velocity, fractional flow reserve, myocardial
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BQ-123 and BQ-788Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
minimal lumen diameter measured directly after infusion of the ET-antagonist(s)
Secondary outcomes (1)
fractional flow reserve, coronary flow reserve, intramyocardial resistance measured directly after infusion of the ET-antagonist(s)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2007 (estimated)
- Study startMay 2003
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary VesselsStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 26 participants
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Thomas Neunteufl, MD, Principal investigator, Dept. of Internal Medicine II, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00427232
- Sponsor's protocol ID
- EK 242/2002
- Status last verified
- Jan 2007
- First submitted
- 25 Jan 2007
- Last updated
- 26 Jan 2007
- Results posted
- No
Publications
Wexberg P, Sperker W, Morgenthaler NG, Heinzl H, Adlbrecht C, Plass C, Glogar HD, Lang IM, Neunteufl T. Inhomogeneous vasomotor effects of moderate selective and non-selective endothelin-receptor blockade in stable coronary artery disease. Heart. 2009 Aug;95(15):1258-64. doi: 10.1136/hrt.2008.158550. Epub 2009 May 3.
PubMed 19414437
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective and Non-Selective Endothelin-Receptor Blockade in Coronary Artey Disease
- ClinicalTrials.gov ID
- NCT00427232
- Acronym / sponsor ID
- EK 242/2002
- Conditions
- Coronary Vessels, Endothelins, Vascular Resistance
- Keywords
- coronary heart disease, endothelins, coronary angiography, blood flow velocity, fractional flow reserve, myocardial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- May 2003
- Study completion
- Aug 2006
- First posted
- 26 Jan 2007 (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.
Endothelin is a hormon that causes acute and chronic narrowing of heart vessels. The purpose of this study is to assess whether suppression of this activity by using two types of receptor antagonists can reduce this effect and thus improve blood supply of the heart muscle.
Detailed description
Endothelin (ET) is the most potent vasoconstrictor known and plays a major role in the development of coronary artery disease as well as in acute vasoconstriction. This effect is mainly mediated by the vascular ET-A receptor, whereas the ET-B receptor mediates vasodilation and cleavage of ET. Currently, there are both selective ET-A antagonists and non-selective ET-A and ET-B antagonists under investigation. The aim of the study is to test the effect of ET-receptor blockade on the vasoreagibility of epicardial and intramyocardial coronary arteries in patients undergoing cardiac catheterization. We randomly use the selective ET-A receptor BQ-123 (Group A) and the combination of BQ-123 and the ET-B receptor antagonist BQ-788 (Group B). The tested infusion will be applied selectively into the assessed coronary artery by a special infusion catheter. To evaluate the morphometric changes we use quantitative coronary angiography to measure the diameter of the coronary artery before and after intracoronary infusion of the tested substances. Furthermore we will use Pressure Wire to measure the hemodynamic conditions before and after infusion, thus evaluating the epicardial and the intramyocardial blood perfusion.
Comparison: Coronary artery diameter as measured by quantitative angiography (minimal lumen diameter) and parameters indicative of epicardial and intramyocardial blood flow as determined by Pressure Wire (fractional flow reserver, coronary flow reserve, intramyocardial resistance) before and after ET-antagonist infusion will be compared.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- coronary artey disease
- stable angina pectoris
- male and post-menopausal female patients
- age above 19 years
- able and willing to conform to the requirements of the study
Key exclusion criteria (17 listed)
- severe focal coronary stenosis
- visually calcified stenosis
- aorto-ostial lesion location and unprotected left main stenosis
- pre-menopausal female patients
- diabetes mellitus
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 |
|---|---|---|
| BQ-123 and BQ-788 | Drug | – |
Primary outcome
minimal lumen diameter measured directly after infusion of the ET-antagonist(s)
1 secondary outcome
fractional flow reserve, coronary flow reserve, intramyocardial resistance measured directly after infusion of the ET-antagonist(s)
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 26 Jan 2007.
- Derived from this study: PubMed 19414437Wexberg P, Sperker W, Morgenthaler NG, Heinzl H, Adlbrecht C, Plass C, Glogar HD, Lang IM, Neunteufl T. Inhomogeneous vasomotor effects of moderate selective and non-selective endothelin-receptor blockade in stable coronary artery disease. Heart. 2009 Aug;95(15):1258-64. doi: 10.1136/hrt.2008.158550. Epub 2009 May 3.
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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.
Thomas Neunteufl, MD principal investigator
Dept. of Internal Medicine II, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BQ-123 and BQ-788 in people with Coronary Vessels and Endothelins, run by Medical University of Vienna at 1 site in Austria.
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 6 inclusion and 17 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 26 Jan 2007. 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 Austria. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
minimal lumen diameter measured directly after infusion of the ET-antagonist(s). 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 NCT00427232, which also lists 1 linked publication.
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 26 Jan 2007.