Coronary Artery DiseaseNCT00310947
Impact of Patient-Prosthesis-Mismatch on Coronary Flow Reserve
An observational study of Coronary Artery Disease, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
Complete normalization of CFR following AVR for aortic stenosis was observed only for stentless valves. Besides the superior hemodynamic performance this might explain the excellent long term results of this valve design. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2005to Jan 2006
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aortic valve stenosis
Who cannot join
- Coronary artery disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Patient-Prosthesis-Mismatch and Aortic Valve Design on Coronary Flow Reserve Following Aortic Valve Replacement
Complete normalization of CFR following AVR for aortic stenosis was observed only for stentless valves. Besides the superior hemodynamic performance this might explain the excellent long term results of this valve design.
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Coronary flow reserve, Heart failure, prospective randomised
- Medical subject headings
- Coronary Artery Disease, Heart Failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2006 (estimated)
- Study startMar 2005
- Study completionJan 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 Artery DiseaseStudies 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
- Observational
- Observational model
- Natural history
- Time perspective
- Prospective
- Enrolment
- 48 participants
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Investigators
- Peter Kleine, MD,PhD, Principal investigator, JW Goethe University Ffm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310947
- Sponsor's protocol ID
- Coronary flow reserve
- Status last verified
- Mar 2003
- First submitted
- 31 Mar 2006
- Last updated
- 5 Apr 2006
- Results posted
- No
Publications
Bakhtiary F, Schiemann M, Dzemali O, Dogan S, Schachinger V, Ackermann H, Moritz A, Kleine P. Impact of patient-prosthesis mismatch and aortic valve design on coronary flow reserve after aortic valve replacement. J Am Coll Cardiol. 2007 Feb 20;49(7):790-6. doi: 10.1016/j.jacc.2006.10.052. Epub 2007 Feb 5.
PubMed 17306709
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Patient-Prosthesis-Mismatch and Aortic Valve Design on Coronary Flow Reserve Following Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT00310947
- Acronym / sponsor ID
- Coronary flow reserve
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Coronary flow reserve, Heart failure, prospective randomised
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Mar 2005
- Study completion
- Jan 2006
- First posted
- 5 Apr 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.
Complete normalization of CFR following AVR for aortic stenosis was observed only for stentless valves. Besides the superior hemodynamic performance this might explain the excellent long term results of this valve design.
Study design
- Observational model
- Natural history
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aortic valve stenosis
Key exclusion criteria (1 listed)
- Coronary artery disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 5 Apr 2006.
- Derived from this study: PubMed 17306709Bakhtiary F, Schiemann M, Dzemali O, Dogan S, Schachinger V, Ackermann H, Moritz A, Kleine P. Impact of patient-prosthesis mismatch and aortic valve design on coronary flow reserve after aortic valve replacement. J Am Coll Cardiol. 2007 Feb 20;49(7):790-6. doi: 10.1016/j.jacc.2006.10.052. Epub 2007 Feb 5.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
Peter Kleine, MD,PhD principal investigator
JW Goethe University Ffm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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 1 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 5 Apr 2006. 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 Germany. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00310947, 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 5 Apr 2006.