Sudden Cardiac DeathCR3NCT04675957
Cardiac Rehab Retrospective Review (CR3)
An observational study of Sudden Cardiac Death and Heart Failure, run by Medical University of Graz at 1 site in Austria.
Trial summary
All patients enrolled in the Austrian LifeVest Registry will be retrospectively screened for successfully completed ambulatory or stationary rehabilitation program. Baseline characteristics, complete rehab data, outcomes and follow up data, as well as wearable cardioverter defibrillator(WCD)-derived data will be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Cardiac Death, Heart Failure, Ventricular Arrythmia
- What is being tested?
- cardiac rehabilitation
- How many people
- 55 participants
- Where
- 1 siteAustria
- Study dates
- 1 Feb 2021to 12 Apr 2022
- 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: All Austrian patients with a WCD having the TRENDS feature who underwent cardiac rehabilitation from 2014-18 will be retrospectively analyzed.
Who may be able to join
- Prescribed WCD as part of the Austrian WCD registry population from 2014-2018
- Partial (>50%) or full completion of a rehabilitation program when wearing the WCD in Austria
- ≥18 years old and able to give informed consent
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
All patients enrolled in the Austrian LifeVest Registry will be retrospectively screened for successfully completed ambulatory or stationary rehabilitation program. Baseline characteristics, complete rehab data, outcomes and follow up data, as well as wearable cardioverter defibrillator(WCD)-derived data will be collected from these patients.
Specifically, performance data from the start of the exercise training (ET) will be compared to the end of ET; including type of training, exertion, time and duration will be collected. In addition, WCD recorded data such as automatically and manually recorded ECGs, compliance, and TRENDS data will be collected.
- Conditions
- Sudden Cardiac Death, Heart Failure, Ventricular Arrythmia, Ventricular Tachycardia, Ventricular Fibrillation
- Being tested
- cardiac rehabilitation
- Keywords
- wearable cardioverter-defibrillator, cardiac rehabilitation
- Medical subject headings
- Death, Sudden, Cardiac, Heart Failure, Tachycardia, Ventricular, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac rehabilitationOther
stationary or ambulatory cardiac rehabilitation
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Arrhythmias (as recorded by clinic or WCD)
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the following data on Arrhythmias captured via WCD or Surface ECG will be collected:
- Atrial tachycardia
- Ventricular tachycardia
- Bradycardia
Measured: 3 months
Number of adequate WCD alarms (as recorded by WCD) per patient
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the number of adequate WCD alarms will be recorded
Measured: 3 months
Number of inadequate WCD alarms (as recorded by WCD) per patient
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the number of inadequate WCD alarms will be recorded
Measured: 3 months
Number of patients with appropriate WCD Shocks
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the number of appropriate WCD shocks will be collected.
Measured: 3 months
Number of patients with Syncopes/Presyncopes
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, data of Syncopes or Pre-Syncopes will be collected.
Measured: 3 months
Number of patients with abnormal blood pressure (measured in mmHg)
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the following data for abnormal blood pressure will be collected:
- Occurrence of Hypotension
- Occurrence of Hypertension
Measured: 3 months
Number of other issues with WCD
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, every data with an issue with WCD disturbing the normal rehabilitation activities will be collected.
Measured: 3 months
Number of other Adverse Events
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, other adverse events recorded by staff during therapy session that stopped ET session (notWCD specific) will be collected.
Measured: 3 months
Number of patients with inappropriate WCD Shocks
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the number of inappropriate WCD shocks (captured via LifeVestNetwork) will be collected.
Measured: 3 months
Secondary outcomes (14)
Difference in physical exercise capacity - measured in METs
The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation.
Measured: 3 months
Performance in ergometry - measured in watts (difference between initial Evaluation and final Evaluation)
The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation.
Measured: 3 months
Body weight - measured in kilogram (difference between initial Evaluation and final Evaluation)
The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation.
Measured: 3 months
Body Mass Index (BMI, weight and height will be combined to report BMI in kg/m^2); (difference between initial Evaluation and final Evaluation)
The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation.
Measured: 3 months
Blood pressure - measured in mmHg (difference between initial Evaluation and final Evaluation)
The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation.
Measured: 3 months
Left ventricular ejection fraction - measured in % (difference between initial Evaluation and final Evaluation)
The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation.
With echocardiography the left ventricular ejection fraction (%) will be collected.
Measured: 3 months
Left ventricular end diastolic diameter (measured in mm)
The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation.
With Echocardiography Left ventricular end diastolic diameter (mm) will be collected.
Measured: 3 months
Size of the Left atrial (measured in mm)
The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation.
With Echocardiography. the size of the Left atrial (mm) will be collected.
Measured: 3 months
Right atrial diameter (measured in mm)
The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation.
With Echocardiography, Right atrial diameter (mm) will be collected.
Measured: 3 months
diastolic dysfunction (measured in grade)
The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation.
With Echocardiography, the diastolic dysfunction (grade) will be collected.
Measured: 3 months
Intraventricular septum (diastolic, measured in mm)
The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation.
With Echocardiography, the Intraventricular septum (diastole, mm) will be collected.
Measured: 3 months
Heart rate derived from the WCD (measured in beats per Minute)
The correlation of WCD-derived parameters such as heart rate with patients' exercise performance during cardiac rehabilitation will primarily be an ad-hoc statistical analyses.
Measured: 3 months
Body Position derived from the WCD
The correlation of WCD-derived parameters such as body position with patients' exercise performance during cardiac rehabilitation will primarily be an ad-hoc statistical analyses. Body position is measured by position sensors.
Measured: 3 months
Step count derived from the WCD (steps/day)
The correlation of WCD-derived parameters such as the step count with patients' exercise performance during cardiac rehabilitation will primarily be an ad-hoc statistical analyses.
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 posted19 Dec 2020
- Study start1 Feb 2021
- Primary completion12 Apr 2022
- Study completion12 Apr 2022
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 Sudden Cardiac DeathStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Zoll Medical Corporation
- Responsible party
- Sponsor
- Investigators
- Daniel Scherr, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675957
- Sponsor's protocol ID
- 90D0204
- Acronym
- CR3
- Status last verified
- Apr 2022
- First submitted
- 19 Oct 2020
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rohrer U, Reischl A, Manninger M, Binder RK, Fiedler L, Gruska M, Altenberger J, Dorr A, Steinwender C, Stuehlinger M, Wonisch M, Zirngast B, Zweiker D, Zirlik A, Scherr D; Austrian WCD Study Group. Cardiovascular Rehabilitation With a WCD-Data From the CR3 Study (Cardiac Rehab Retrospective Review). J Cardiopulm Rehabil Prev. 2024 Mar 1;44(2):115-120. doi: 10.1097/HCR.0000000000000832. Epub 2023 Nov 30.
PubMed 38032261
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Rehab Retrospective Review (CR3)
- ClinicalTrials.gov ID
- NCT04675957
- Acronym / sponsor ID
- CR3 / 90D0204
- Conditions
- Sudden Cardiac Death, Heart Failure, Ventricular Arrythmia, Ventricular Tachycardia, Ventricular Fibrillation
- Keywords
- wearable cardioverter-defibrillator, cardiac rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Zoll Medical Corporation
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 12 Apr 2022 (actual)
- Study completion
- 12 Apr 2022 (actual)
- First posted
- 19 Dec 2020 (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.
All patients enrolled in the Austrian LifeVest Registry will be retrospectively screened for successfully completed ambulatory or stationary rehabilitation program. Baseline characteristics, complete rehab data, outcomes and follow up data, as well as wearable cardioverter defibrillator(WCD)-derived data will be collected from these patients.
Specifically, performance data from the start of the exercise training (ET) will be compared to the end of ET; including type of training, exertion, time and duration will be collected. In addition, WCD recorded data such as automatically and manually recorded ECGs, compliance, and TRENDS data will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All Austrian patients with a WCD having the TRENDS feature who underwent cardiac rehabilitation from 2014-18 will be retrospectively analyzed.
Key inclusion criteria (3 listed)
- Prescribed WCD as part of the Austrian WCD registry population from 2014-2018
- Partial (>50%) or full completion of a rehabilitation program when wearing the WCD in Austria
- ≥18 years old and able to give informed consent
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| cardiac rehabilitationstationary or ambulatory cardiac rehabilitation | Other | – |
Primary outcome
Number of Arrhythmias (as recorded by clinic or WCD)
Time frame: 3 months
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the following data on Arrhythmias captured via WCD or Surface ECG will be collected: * Atrial tachycardia * Ventricular tachycardia * Bradycardia
Number of adequate WCD alarms (as recorded by WCD) per patient
Time frame: 3 months
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the number of adequate WCD alarms will be recorded
Number of inadequate WCD alarms (as recorded by WCD) per patient
Time frame: 3 months
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the number of inadequate WCD alarms will be recorded
Number of patients with appropriate WCD Shocks
Time frame: 3 months
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the number of appropriate WCD shocks will be collected.
Number of patients with Syncopes/Presyncopes
Time frame: 3 months
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, data of Syncopes or Pre-Syncopes will be collected.
Number of patients with abnormal blood pressure (measured in mmHg)
Time frame: 3 months
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the following data for abnormal blood pressure will be collected: * Occurrence of Hypotension * Occurrence of Hypertension
Number of other issues with WCD
Time frame: 3 months
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, every data with an issue with WCD disturbing the normal rehabilitation activities will be collected.
Number of other Adverse Events
Time frame: 3 months
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, other adverse events recorded by staff during therapy session that stopped ET session (notWCD specific) will be collected.
Number of patients with inappropriate WCD Shocks
Time frame: 3 months
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the number of inappropriate WCD shocks (captured via LifeVestNetwork) will be collected.
14 secondary outcomes
Difference in physical exercise capacity - measured in METs
Time frame: 3 months
Performance in ergometry - measured in watts (difference between initial Evaluation and final Evaluation)
Time frame: 3 months
Body weight - measured in kilogram (difference between initial Evaluation and final Evaluation)
Time frame: 3 months
Body Mass Index (BMI, weight and height will be combined to report BMI in kg/m^2); (difference between initial Evaluation and final Evaluation)
Time frame: 3 months
Blood pressure - measured in mmHg (difference between initial Evaluation and final Evaluation)
Time frame: 3 months
Left ventricular ejection fraction - measured in % (difference between initial Evaluation and final Evaluation)
Time frame: 3 months
Left ventricular end diastolic diameter (measured in mm)
Time frame: 3 months
Size of the Left atrial (measured in mm)
Time frame: 3 months
Right atrial diameter (measured in mm)
Time frame: 3 months
diastolic dysfunction (measured in grade)
Time frame: 3 months
Intraventricular septum (diastolic, measured in mm)
Time frame: 3 months
Heart rate derived from the WCD (measured in beats per Minute)
Time frame: 3 months
Body Position derived from the WCD
Time frame: 3 months
Step count derived from the WCD (steps/day)
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 14 Apr 2022.
- Derived from this study: PubMed 38032261Rohrer U, Reischl A, Manninger M, Binder RK, Fiedler L, Gruska M, Altenberger J, Dorr A, Steinwender C, Stuehlinger M, Wonisch M, Zirngast B, Zweiker D, Zirlik A, Scherr D; Austrian WCD Study Group. Cardiovascular Rehabilitation With a WCD-Data From the CR3 Study (Cardiac Rehab Retrospective Review). J Cardiopulm Rehabil Prev. 2024 Mar 1;44(2):115-120. doi: 10.1097/HCR.0000000000000832. Epub 2023 Nov 30.
- Individual participant dataSharing planned: No
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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.
Daniel Scherr, MD principal investigator
Medical University of Graz
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 Sudden Cardiac Death and Heart Failure, run by Medical University of Graz 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 3 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 14 Apr 2022. 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.
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?
Number of Arrhythmias (as recorded by clinic or WCD) (time frame: 3 months). The study lists 9 primary outcomes in all. 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 NCT04675957, 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 14 Apr 2022.