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Quality of Care in AS IMPULSE Study (IMPULSE)

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ClinicalTrials.gov Identifier: NCT02241447
Recruitment Status : Completed
First Posted : September 16, 2014
Last Update Posted : June 13, 2018
Sponsor:
Collaborator:
Edwards Lifesciences
Information provided by (Responsible Party):
Institut für Pharmakologie und Präventive Medizin

Brief 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 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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Other: Early Information Not Applicable

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 at the hub AND the satellite 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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2173 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Study to Improve Outcomes in Aortic Stenosis. International, Multi-center, Prospective, Observation and Interventional Cohort Study
Study Start Date : August 2014
Actual Primary Completion Date : May 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Observation
the nurse identifies cases with severe AS at the hub AND the satellite 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.
Other: Early Information
Nurse based at echo facility will inform referring physician within one week that their Patient was diagnosed with severe aortic Stenosis. outcomes and Treatment decision will be documented.




Primary Outcome Measures :
  1. Referral rates at 3 months for Intervention (SAVR or TAVI) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Referral rates at 3 months for exercise testing or stress echocardiography [ Time Frame: 3 months ]
  2. Time to next out-patient appointment or clinical review [ Time Frame: 15 months ]
  3. Type of intervention selected (SAVR, TAVI, watchful waiting or no treatment) [ Time Frame: 3 months ]
  4. Appropriateness of treatment decisions made in collaboration with the valve specialist [ Time Frame: 3 months ]
  5. Outcomes (survival) at 1 year (telephone FU) including the time between diagnosis and treatment [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aortic valve area < 1cm2
  • Indexed aortic valve area <0.6 cm/m2
  • Maximum Jet velocity > 4.0 m/sec
  • Mean transvalvular gradient > 40 mmHg

Exclusion Criteria:

  • Non-severe aortic Stenosis (AS)
  • Previous aortic valve replacement (AVR)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02241447


Locations
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Austria
Krankenhaus Hietzing
Wien, Austria, 1130
Czechia
IKEM - Institute for Clinical and Experimental Medicine
Prag, Czechia, 140 21
France
Centre Hospitalier d'Annecy
Annecy, France, 74374
Bichat Hospital
Paris, France, 75018
Germany
Charité - Campus Benjamin Franklin
Berlin, Germany, 10233
Universitätsklinikum Erlangen
Erlangen, Germany, 91054
Westpfalz Klinikum
Kaiserslautern, Germany, 67655
UKSK Campus Kiel, Klinik für Kardiologie und Angiologie
Kiel, Germany, 24105
Herzzentrum Universitätsklinikum Köln
Köln, Germany, 50924
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany, 55131
Städtisches Klinikum München
München, Germany, 80337
Krankenhaus der Barmherzigen Brüder
Trier, Germany, 54292
Italy
Università degli Studi di Bari Aldo Moro
Bari, Italy, 70121
University "Magna Græcia" of Catanzaro
Catanzaro, Italy, 88100
IRCCS San Matteo Hospital
Pavia, Italy, 27100
Policlinico Umberto I Rom
Rom, Italy, 00161
University of Torino
Torino, Italy
Netherlands
AMC Medical Center
Amsterdam, Netherlands, 1105
Spain
Santa Creu Barcelona
Barcelona, Spain, 08025
Switzerland
UniversitätsSpital Zürich
Zürich, Switzerland, 8091
United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH
Bart Heart Center
London, United Kingdom, E1 1BB
James Cook University Hospital
Middlesbrough, United Kingdom, TS4 3BW
Sponsors and Collaborators
Institut für Pharmakologie und Präventive Medizin
Edwards Lifesciences
Investigators
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Principal Investigator: Richard Steeds, MD Queen Elizabeth Hospital, Birmingham, UK
Principal Investigator: Norbert Frey, MD Department of Cardiology and Angiology, University of Kiel, Germany
Principal Investigator: Davia Messika-Zeitoun, MD Hôpital Bichat, Paris FR

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Responsible Party: Institut für Pharmakologie und Präventive Medizin
ClinicalTrials.gov Identifier: NCT02241447     History of Changes
Other Study ID Numbers: IMPULSE
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Institut für Pharmakologie und Präventive Medizin:
aortic valve Stenosis
Echo
TAVI
SAVR
referral

Additional relevant MeSH terms:
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Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction