Aortic Valve StenosisIMPULSENCT02241447
Quality of Care in AS IMPULSE Study
An observational study of Aortic Valve Stenosis, run by Institut für Pharmakologie und Präventive Medizin at 23 sites in 9 countries.
Trial summary
The purpose of this study is to narrow the gap between patients being diagnosed with severe aortic stenosis and those being appropriately monitored and treated. For this purpose a prospective survey of current practice (3 months) will be conducted followed by a six month period of intervention during which a variety… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- How many people
- 2,173 participants
- Where
- 23 sitesin 9 countries
- Study dates
- 8 Aug 2014to 31 May 2018
- How long will I take part?
- 3 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged over 18years identified on echocardiography with severe AS
Who may be able to join
- Aortic valve area < 1cm2
- Indexed aortic valve area <0.6 cm/m2
- Maximum Jet velocity > 4.0 m/sec
- Mean transvalvular gradient > 40 mmHg
Who cannot join
- Non-severe aortic Stenosis (AS)
- Previous aortic valve replacement (AVR)
Trial locations and contacts
23 sites in 9 countries.
23 sites in 9 countries
Germany8 sites
Charité - Campus Benjamin Franklin
Berlin, 10233
Herzzentrum Universitätsklinikum Köln
Cologne, 50924
Universitätsklinikum Erlangen
Erlangen, 91054
Westpfalz Klinikum
Kaiserslautern, 67655
UKSK Campus Kiel, Klinik für Kardiologie und Angiologie
Kiel, 24105
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
Städtisches Klinikum München
München, 80337
Krankenhaus der Barmherzigen Brüder
Trier, 54292
Italy5 sites
Università degli Studi di Bari Aldo Moro
Bari, 70121
University "Magna Græcia" of Catanzaro
Catanzaro, 88100
IRCCS San Matteo Hospital
Pavia, 27100
Policlinico Umberto I Rom
Rome, 00161
University of Torino
Torino
United Kingdom3 sites
Queen Elizabeth Hospital
Birmingham, B15 2TH
Bart Heart Center
London, E1 1BB
James Cook University Hospital
Middlesbrough, TS4 3BW
France2 sites
Centre Hospitalier d'Annecy
Annecy, 74374
Bichat Hospital
Paris, 75018
Czechia1 site
IKEM - Institute for Clinical and Experimental Medicine
Prague, 140 21
About this study
Official title: Study to Improve Outcomes in Aortic Stenosis. International, Multi-center, Prospective, Observation and Interventional Cohort Registry
The purpose of this study is to narrow the gap between patients being diagnosed with severe aortic stenosis and those being appropriately monitored and treated. For this purpose a prospective survey of current practice (3 months) will be conducted followed by a six month period of intervention during which a variety of quality improvements measures will be implemented. There will then be a 3 month follow-up period during which the legacy of this initiative will be monitored during which no intervention will be carried out.
Read the detailed description
All patients meeting pre-specified criteria (severe aortic stenosis whether with or without symptoms) will be collected. There will be three phases at each site observation A, intervention, observation B. Observation A: In this phase, the nurse identifies cases with severe AS and collects their data. Baseline data for each patient will be collected and a follow-up will be done after three months for each patient to determine his/her outcome and the treatment that was decided on. There will also be an optional telephone follow-up to find out the patient's outcome.
Intervention: In this phase, the physician referring a patient for echocardiography will be notified of a finding of severe aortic stenosis: the nurse brings cases with severe AS to the attention of the referring physician within a week (via phone, e-mail or letter) to make them aware of the diagnosis.
Baseline and follow-up data will be collected for each patient as before. Moreover, more detailed data with regard to the patient's health status will be documented.
Observation B: Same as Observation Phase A
- Conditions
- Aortic Valve Stenosis
- Keywords
- aortic valve Stenosis, Echo, TAVI, SAVR, referral
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observation | the nurse identifies cases with severe AS and collects their data. Baseline data for each patient will be collected and a follow-up will be done after three months for each patient to determine his/her outcome and the treatment that was decided on | |
| Early information | in this arm, the physician referring a patient for echocardiography will be notified of a finding of severe aortic stenosis: the nurse brings cases with severe AS to the attention of the referring physician within a week (via phone, e-mail or letter) to make them aware of the diagnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Referral rates at 3 months for Intervention (SAVR or TAVI)
Measured: 3 months
Secondary outcomes (5)
Referral rates at 3 months for exercise testing or stress echocardiography
Measured: 3 months
Time to next out-patient appointment or clinical review
Measured: 15 months
Type of intervention selected (SAVR, TAVI, watchful waiting or no treatment)
Measured: 3 months
Appropriateness of treatment decisions made in collaboration with the valve specialist
Measured: 3 months
Outcomes (survival) at 1 year (telephone FU) including the time between diagnosis and treatment
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 posted16 Sep 2014 (estimated)
- Study start8 Aug 2014
- Primary completion15 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 2,173 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Institut für Pharmakologie und Präventive Medizin
- Sponsor type
- Research network
- Collaborators
- Edwards Lifesciences
- Responsible party
- Sponsor
- Investigators
- Richard Steeds, MD, Principal investigator, Queen Elizabeth Hospital, Birmingham, UKNorbert Frey, MD, Principal investigator, Department of Cardiology and Angiology, University of Kiel, GermanyDavia Messika-Zeitoun, MD, Principal investigator, Hôpital Bichat, Paris FR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241447
- Sponsor's protocol ID
- IMPULSE
- Acronym
- IMPULSE
- Status last verified
- Mar 2020
- First submitted
- 2 Sep 2014
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Steeds RP, Lutz M, Thambyrajah J, Serra A, Schulz E, Maly J, Aiello M, Rudolph TK, Lloyd G, Bortone AS, Hauptmann KE, Clerici A, Delle-Karth G, Rieber J, Indolfi C, Mancone M, Belle L, Lauten A, Arnold M, Bouma BJ, Deutsch C, Kurucova J, Thoenes M, Bramlage P, Frey N, Messika-Zeitoun D. Facilitated Data Relay and Effects on Treatment of Severe Aortic Stenosis in Europe. J Am Heart Assoc. 2019 Oct;8(19):e013160. doi: 10.1161/JAHA.119.013160. Epub 2019 Sep 24.
PubMed 31549578Frey N, Steeds RP, Rudolph TK, Thambyrajah J, Serra A, Schulz E, Maly J, Aiello M, Lloyd G, Bortone AS, Hauptmann KE, Clerici A, Delle Karth G, Rieber J, Indorfi C, Mancone M, Belle L, Lauten A, Arnold M, Bouma BJ, Lutz M, Pohlmann C, Kurucova J, Thoenes M, Bramlage P, Messika-Zeitoun D; IMPULSE registry group. Symptoms, disease severity and treatment of adults with a new diagnosis of severe aortic stenosis. Heart. 2019 Nov;105(22):1709-1716. doi: 10.1136/heartjnl-2019-314940. Epub 2019 Jul 13.
PubMed 31302639
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Improve Outcomes in Aortic Stenosis. International, Multi-center, Prospective, Observation and Interventional Cohort Registry
- ClinicalTrials.gov ID
- NCT02241447
- Acronym / sponsor ID
- IMPULSE / IMPULSE
- Conditions
- Aortic Valve Stenosis
- Keywords
- aortic valve Stenosis, Echo, TAVI, SAVR, referral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,173 participants (actual)
- Lead sponsor
- Institut für Pharmakologie und Präventive MedizinResearch network
- Collaborators
- Edwards Lifesciences
- Study start
- 8 Aug 2014 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 16 Sep 2014 (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 purpose of this study is to narrow the gap between patients being diagnosed with severe aortic stenosis and those being appropriately monitored and treated. For this purpose a prospective survey of current practice (3 months) will be conducted followed by a six month period of intervention during which a variety of quality improvements measures will be implemented. There will then be a 3 month follow-up period during which the legacy of this initiative will be monitored during which no intervention will be carried out.
Detailed description
All patients meeting pre-specified criteria (severe aortic stenosis whether with or without symptoms) will be collected. There will be three phases at each site observation A, intervention, observation B. Observation A: In this phase, the nurse identifies cases with severe AS and collects their data. Baseline data for each patient will be collected and a follow-up will be done after three months for each patient to determine his/her outcome and the treatment that was decided on. There will also be an optional telephone follow-up to find out the patient's outcome.
Intervention: In this phase, the physician referring a patient for echocardiography will be notified of a finding of severe aortic stenosis: the nurse brings cases with severe AS to the attention of the referring physician within a week (via phone, e-mail or letter) to make them aware of the diagnosis.
Baseline and follow-up data will be collected for each patient as before. Moreover, more detailed data with regard to the patient's health status will be documented.
Observation B: Same as Observation Phase A
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation | – | –the nurse identifies cases with severe AS and collects their data. Baseline data for each patient will be collected and a follow-up will be done after three months for each patient to determine his/her outcome and the treatment that was decided on |
| Early information | – | –in this arm, the physician referring a patient for echocardiography will be notified of a finding of severe aortic stenosis: the nurse brings cases with severe AS to the attention of the referring physician within a week (via phone, e-mail or letter) to make them aware of the diagnosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged over 18years identified on echocardiography with severe AS
Key inclusion criteria (4 listed)
- Aortic valve area < 1cm2
- Indexed aortic valve area <0.6 cm/m2
- Maximum Jet velocity > 4.0 m/sec
- Mean transvalvular gradient > 40 mmHg
Key exclusion criteria (2 listed)
- Non-severe aortic Stenosis (AS)
- Previous aortic valve replacement (AVR)
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
Referral rates at 3 months for Intervention (SAVR or TAVI)
Time frame: 3 months
5 secondary outcomes
Referral rates at 3 months for exercise testing or stress echocardiography
Time frame: 3 months
Time to next out-patient appointment or clinical review
Time frame: 15 months
Type of intervention selected (SAVR, TAVI, watchful waiting or no treatment)
Time frame: 3 months
Appropriateness of treatment decisions made in collaboration with the valve specialist
Time frame: 3 months
Outcomes (survival) at 1 year (telephone FU) including the time between diagnosis and treatment
Time frame: 3 months
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 4 Mar 2020.
- Derived from this study: PubMed 31549578Steeds RP, Lutz M, Thambyrajah J, Serra A, Schulz E, Maly J, Aiello M, Rudolph TK, Lloyd G, Bortone AS, Hauptmann KE, Clerici A, Delle-Karth G, Rieber J, Indolfi C, Mancone M, Belle L, Lauten A, Arnold M, Bouma BJ, Deutsch C, Kurucova J, Thoenes M, Bramlage P, Frey N, Messika-Zeitoun D. Facilitated Data Relay and Effects on Treatment of Severe Aortic Stenosis in Europe. J Am Heart Assoc. 2019 Oct;8(19):e013160. doi: 10.1161/JAHA.119.013160. Epub 2019 Sep 24.
- Derived from this study: PubMed 31302639Frey N, Steeds RP, Rudolph TK, Thambyrajah J, Serra A, Schulz E, Maly J, Aiello M, Lloyd G, Bortone AS, Hauptmann KE, Clerici A, Delle Karth G, Rieber J, Indorfi C, Mancone M, Belle L, Lauten A, Arnold M, Bouma BJ, Lutz M, Pohlmann C, Kurucova J, Thoenes M, Bramlage P, Messika-Zeitoun D; IMPULSE registry group. Symptoms, disease severity and treatment of adults with a new diagnosis of severe aortic stenosis. Heart. 2019 Nov;105(22):1709-1716. doi: 10.1136/heartjnl-2019-314940. Epub 2019 Jul 13.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Richard Steeds, MD principal investigator
Queen Elizabeth Hospital, Birmingham, UK
Norbert Frey, MD principal investigator
Department of Cardiology and Angiology, University of Kiel, Germany
Davia Messika-Zeitoun, MD principal investigator
Hôpital Bichat, Paris FR
23 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by Institut für Pharmakologie und Präventive Medizin at 23 sites in 9 countries.
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 4 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 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Germany, Italy, United Kingdom, France, Austria and 4 more countries. 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?
Referral rates at 3 months for Intervention (SAVR or TAVI) (time frame: 3 months). 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 NCT02241447, which also lists 2 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 4 Mar 2020.