Aortic Valve StenosisTAVI PETNCT04882488
Correlation of FFR and iFR With Cardiac PET Perfusion in Patients With Severe Aortic Valve Stenosis
An observational study of Aortic Valve Stenosis and Coronary Artery Disease, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
Trial summary
Aortic valve stenosis (AS) affects 2-7% of persons > 65 years, symptoms include: angina and dyspnea, dizziness and syncope. Coincidence of coronary artery disease (CAD), also presenting with angina and dyspnea, in patients with AS between 40 - 65% . Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Coronary Artery Disease
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2021to 30 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients with severe aortic Stenosis eligible for transcatheter aortic Valve Implantation (TAVI) with concurring coronary artery disease.
Who may be able to join
- patients with severe aortic Stenosis eligible for transcatheter aortic stenosis
- left ventricular ejection fraction > 55%
- no intolerance of Adenosin
- no history of bradycardia, atrioventricular Blockade
- intermediate coronary Stenosis with FFR> 0.8
- Age >65
Who cannot join
- intolerance of Adenosin
- left ventricular ejection fraction < 55%
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Herz- und Diabeteszentrum, NRW
Bad Oeynhausen, North Rhine-Westphalia, 32545
Tanja K Rudolph, MD, 00495731971258, trudolph@hdz-nrw.de
About this study
Official title: Correlation of FFR and iFR With Cardiac PET Perfusion (at Rest and Under Adenosine) in the Evaluation of Intermediate Coronary Stenoses in Patients With Severe Aortic Valve Stenosis
Aortic valve stenosis (AS) affects 2-7% of persons > 65 years, symptoms include: angina and dyspnea, dizziness and syncope. Coincidence of coronary artery disease (CAD), also presenting with angina and dyspnea, in patients with AS between 40 - 65% . Angina in AS caused by significant reduction of coronary flow reserve (CFR). CFR is the ratio of maximal flow increase in the coronary vessel bed during maximal hyperaemia (medically or exercise induced). FFR (fractional flow reserve) use in patients with AS potentially invalid due to dysfunctional CFR leading to potential undertreatment of CAD in these patients.CFR disturbance in AS mainly due to myocardial overload causing concentric hypertrophy, increased oxygen consumption and neurohormonal activation leading to increased vascular resistance. Current studies are investigating the validity of FFR and iFR in AS patients. Recent data demonstrate very good correlation between FFR and iFR derived values to PET myocardial perfusion imaging values in patients with no evidence of AS. Our study aims to investigate the diagnostic performance of FFR and iFR in intermediate-grade coronary stenosis in patients with severe aortic valve disease and correlate FFR- and iFR derived values with those extracted from PET-perfusion Imaging.
- Conditions
- Aortic Valve Stenosis, Coronary Artery Disease
- Keywords
- Aortic valve stenosis, PET-CT, coronary artery disease, FFR
- Medical subject headings
- Aortic Valve Stenosis, Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of PET-CT Prior to TAVI and 3 months after TAVI procedure
Evaluation of FFR-negative intermediary coronary stenoses in Patients with severe Aortic Stenosis Prior and 3 months following TAVI
Measured: 3 months
Secondary outcomes (1)
Clinical Evaluation Prior to and following TAVI
Angina prevalence in patients with intermediate coronary Stenosis Prior to and 3 months following TAVI
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start1 Jun 2021
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heart and Diabetes Center North-Rhine Westfalia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tanja Rudolph, MD, Principal investigator, Consultant physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882488
- Sponsor's protocol ID
- HDZ-KA_020_TR
- Acronym
- TAVI PET
- Status last verified
- Nov 2024
- First submitted
- 6 May 2021
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of FFR and iFR With Cardiac PET Perfusion (at Rest and Under Adenosine) in the Evaluation of Intermediate Coronary Stenoses in Patients With Severe Aortic Valve Stenosis
- ClinicalTrials.gov ID
- NCT04882488
- Acronym / sponsor ID
- TAVI PET / HDZ-KA_020_TR
- Conditions
- Aortic Valve Stenosis, Coronary Artery Disease
- Keywords
- Aortic valve stenosis, PET-CT, coronary artery disease, FFR
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Heart and Diabetes Center North-Rhine WestfaliaUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 12 May 2021 (actual)
- 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.
Aortic valve stenosis (AS) affects 2-7% of persons > 65 years, symptoms include: angina and dyspnea, dizziness and syncope. Coincidence of coronary artery disease (CAD), also presenting with angina and dyspnea, in patients with AS between 40 - 65% . Angina in AS caused by significant reduction of coronary flow reserve (CFR). CFR is the ratio of maximal flow increase in the coronary vessel bed during maximal hyperaemia (medically or exercise induced). FFR (fractional flow reserve) use in patients with AS potentially invalid due to dysfunctional CFR leading to potential undertreatment of CAD in these patients.CFR disturbance in AS mainly due to myocardial overload causing concentric hypertrophy, increased oxygen consumption and neurohormonal activation leading to increased vascular resistance. Current studies are investigating the validity of FFR and iFR in AS patients. Recent data demonstrate very good correlation between FFR and iFR derived values to PET myocardial perfusion imaging values in patients with no evidence of AS. Our study aims to investigate the diagnostic performance of FFR and iFR in intermediate-grade coronary stenosis in patients with severe aortic valve disease and correlate FFR- and iFR derived values with those extracted from PET-perfusion Imaging.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients with severe aortic Stenosis eligible for transcatheter aortic Valve Implantation (TAVI) with concurring coronary artery disease.
Key inclusion criteria (6 listed)
- patients with severe aortic Stenosis eligible for transcatheter aortic stenosis
- left ventricular ejection fraction > 55%
- no intolerance of Adenosin
- no history of bradycardia, atrioventricular Blockade
- intermediate coronary Stenosis with FFR> 0.8
Key exclusion criteria (2 listed)
- intolerance of Adenosin
- left ventricular ejection fraction < 55%
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
Correlation of PET-CT Prior to TAVI and 3 months after TAVI procedure
Time frame: 3 months
Evaluation of FFR-negative intermediary coronary stenoses in Patients with severe Aortic Stenosis Prior and 3 months following TAVI
1 secondary outcome
Clinical Evaluation Prior to and following TAVI
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
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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.
Tanja Rudolph, MD principal investigator
Consultant physician
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 Aortic Valve Stenosis and Coronary Artery Disease, run by Heart and Diabetes Center North-Rhine Westfalia 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 6 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: looking for participants now, as of the sponsor's last update on 26 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tanja Rudolph, MD (+495731971258, trudolph@hdz-nrw.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of PET-CT Prior to TAVI and 3 months after TAVI procedure (time frame: 3 months). 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 26 Nov 2024.