Ventricular ArrhythmiasSMASH 1NCT02864771
Scandinavian Multicenter Study to Advance Risk Stratification in Heart Disease- Ventricular Arrhythmias
An observational study of Ventricular Arrhythmias and Implantable Defibrillator User, run by University Hospital, Akershus at 1 site in Norway.
Trial summary
The purpose of this study is to identify markers of increased risk for incident ventricular arrhythmias and cardiovascular events in patients already being treated with an implantable cardioverter-defibrillator (ICD) by exploring patient history and clinical findings, biological markers, ECG markers, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Arrhythmias, Implantable Defibrillator User, Biological Markers
- How many people
- 504 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2016to Dec 2050
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with an ICD. Inclusion from outpatient clinic.
Who may be able to join
- Patients ≥ 18 years old
- Current treatment with an ICD
- Signed written informed consent before study commencement
Who cannot join
- Participation in other interventional clinical trial or previously included in the current study
- Patients not able to provide written informed consent
- Known or suspected, non-curable cancer,
- Neurological condition with short life expectancy; e.g. amyotropic lateral sclerosis (ALS)
- Patients unwilling or unable to comply with the protocol
- History of non-compliance to medical management and patients who are considered potentially unreliable by the Investigator
- History or evidence of alcohol or drug abuse with the last 12 months that may influence the participation of the patient in the study, as assessed by the Investigator during the screening phase
- Any surgical or medical condition, which in the option of the Investigator, will impair the ability of the patient to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scandinavian Multicenter Study to Advance Risk Stratification in Heart Disease- Ventricular Arrhythmias: A Multicenter, Observational Trial
The purpose of this study is to identify markers of increased risk for incident ventricular arrhythmias and cardiovascular events in patients already being treated with an implantable cardioverter-defibrillator (ICD) by exploring patient history and clinical findings, biological markers, ECG markers, and echocardiographic markers.
Read the detailed description
This is a multicenter prospective cohort study to assess the prognostic value of potential biomarkers for incident ventricular arrhythmias and cardiovascular events in patients with implantable cardioverter-defibrillator (ICD). In addition to information from the baseline visit and future study visits, the investigators will also register information from the patients medical records concerning comorbidities and previous medical events.
The data will be summarized with respect to demographic and baseline characteristics and risk markers/ measurements. The final diagnosis of incident cardiovascular events will be established by an adjudication committee with two senior physicians reviewing all information available on the patients, including information on the clinical outcome of the patient. The investigators will use multivariate statistical models to assess the individual performance of biomarkers/other tests.
- Conditions
- Ventricular Arrhythmias, Implantable Defibrillator User, Biological Markers, Heart Disease
- Keywords
- Ventricular Arrhythmias, ICD, Biological markers
- Medical subject headings
- Heart Diseases
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 |
|---|---|---|
| 1 | Derivation cohort (n=474); may be analyzed separately or combined with cohort #2 to enhance statistical power | |
| 2 | Validation cohort (patient #475 and after); may be combined with cohort #1 to enhance statistical power |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episodes of ventricular fibrillation (VF) or ventricular tachycardia (VT) resulting in appropriately delivered ICD therapies (including antitachycardia pacing) or sustained ventricular tachyarrhythmia (>100/min, >30sek).
Registered from the monitoring function of the ICD
Measured: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
Secondary outcomes (8)
All-cause mortality
Measured: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
Cardiovascular mortality
Measured: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
Major adverse cardiac event (MACE), i.e. acute myocardial infarction, stroke, urgent myocardial revascularization and cardiovascular mortality
Measured: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
Heart failure hospitalization
Measured: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
The combination of cardiovascular mortality and heart failure hospitalizations
Measured: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
Number of premature ventricular complexes (PVCs) and non-sustained VT (> 3 coupled PVCs) registered from the monitoring function of the ICD
Measured: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
New occurrence of supra-ventricular arrhythmias (i.e. atrial fibrillation, atrial flutter, atrial tachycardia etc.)
Measured: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
Episodes of ventricular- or supra-ventricular arrhythmias (specified above) registered from the monitoring function of the ICD.
Measured: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startAug 2016
- Primary completion31 Dec 2019
- Study completionDec 2050 (estimated)
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 Ventricular ArrhythmiasStudies 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
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Stavanger HF, University of Oslo
- Responsible party
- Principal investigator, Torbjorn Omland, University Hospital, Akershus
- Investigators
- Torbjørn Omland, MD,PhD, MPH, Principal investigator, Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864771
- Sponsor's protocol ID
- 2015/2080
- Acronym
- SMASH 1
- Status last verified
- Jun 2020
- First submitted
- 1 Jul 2016
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Sourour N, Riveland E, Naesgaard P, Kjekshus H, Larsen AI, Rosjo H, Omland T, Myhre PL. Associations Between Biomarkers of Myocardial Injury and Systemic Inflammation and Risk of Incident Ventricular Arrhythmia. JACC Clin Electrophysiol. 2024 Sep;10(9):2021-2032. doi: 10.1016/j.jacep.2024.04.017. Epub 2024 Jun 19.
PubMed 38904572
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scandinavian Multicenter Study to Advance Risk Stratification in Heart Disease- Ventricular Arrhythmias: A Multicenter, Observational Trial
- ClinicalTrials.gov ID
- NCT02864771
- Acronym / sponsor ID
- SMASH 1 / 2015/2080
- Conditions
- Ventricular Arrhythmias, Implantable Defibrillator User, Biological Markers, Heart Disease
- Keywords
- Ventricular Arrhythmias, ICD, Biological markers
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 504 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- Helse Stavanger HF, University of Oslo
- Study start
- Aug 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- Dec 2050 (estimated)
- First posted
- 12 Aug 2016 (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 identify markers of increased risk for incident ventricular arrhythmias and cardiovascular events in patients already being treated with an implantable cardioverter-defibrillator (ICD) by exploring patient history and clinical findings, biological markers, ECG markers, and echocardiographic markers.
Detailed description
This is a multicenter prospective cohort study to assess the prognostic value of potential biomarkers for incident ventricular arrhythmias and cardiovascular events in patients with implantable cardioverter-defibrillator (ICD). In addition to information from the baseline visit and future study visits, the investigators will also register information from the patients medical records concerning comorbidities and previous medical events.
The data will be summarized with respect to demographic and baseline characteristics and risk markers/ measurements. The final diagnosis of incident cardiovascular events will be established by an adjudication committee with two senior physicians reviewing all information available on the patients, including information on the clinical outcome of the patient. The investigators will use multivariate statistical models to assess the individual performance of biomarkers/other tests.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Derivation cohort (n=474); may be analyzed separately or combined with cohort #2 to enhance statistical power |
| 2 | – | –Validation cohort (patient #475 and after); may be combined with cohort #1 to enhance statistical power |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with an ICD. Inclusion from outpatient clinic.
Key inclusion criteria (3 listed)
- Patients ≥ 18 years old
- Current treatment with an ICD
- Signed written informed consent before study commencement
Key exclusion criteria (8 listed)
- Participation in other interventional clinical trial or previously included in the current study
- Patients not able to provide written informed consent
- Known or suspected, non-curable cancer,
- Neurological condition with short life expectancy; e.g. amyotropic lateral sclerosis (ALS)
- Patients unwilling or unable to comply with the protocol
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
Episodes of ventricular fibrillation (VF) or ventricular tachycardia (VT) resulting in appropriately delivered ICD therapies (including antitachycardia pacing) or sustained ventricular tachyarrhythmia (>100/min, >30sek).
Time frame: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
Registered from the monitoring function of the ICD
8 secondary outcomes
All-cause mortality
Time frame: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
Cardiovascular mortality
Time frame: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
Major adverse cardiac event (MACE), i.e. acute myocardial infarction, stroke, urgent myocardial revascularization and cardiovascular mortality
Time frame: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
Heart failure hospitalization
Time frame: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
The combination of cardiovascular mortality and heart failure hospitalizations
Time frame: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
Number of premature ventricular complexes (PVCs) and non-sustained VT (> 3 coupled PVCs) registered from the monitoring function of the ICD
Time frame: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
New occurrence of supra-ventricular arrhythmias (i.e. atrial fibrillation, atrial flutter, atrial tachycardia etc.)
Time frame: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
Episodes of ventricular- or supra-ventricular arrhythmias (specified above) registered from the monitoring function of the ICD.
Time frame: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
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 4 Jun 2020.
- Derived from this study: PubMed 38904572Sourour N, Riveland E, Naesgaard P, Kjekshus H, Larsen AI, Rosjo H, Omland T, Myhre PL. Associations Between Biomarkers of Myocardial Injury and Systemic Inflammation and Risk of Incident Ventricular Arrhythmia. JACC Clin Electrophysiol. 2024 Sep;10(9):2021-2032. doi: 10.1016/j.jacep.2024.04.017. Epub 2024 Jun 19.
- Individual participant dataSharing planned: Undecided
Related trials for Ventricular Arrhythmias
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EDEN Intracardiac Electrogram Recording and Classifying System
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Assessment of Combined CCM and ICD Device in HFrEF
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Physical Impairments in Premature Ventricular Complex
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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.
Torbjørn Omland, MD,PhD, MPH principal investigator
Professor of Medicine
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 Ventricular Arrhythmias and Implantable Defibrillator User, run by University Hospital, Akershus at 1 site in Norway.
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 8 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: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2020. 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 Norway. 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?
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?
Episodes of ventricular fibrillation (VF) or ventricular tachycardia (VT) resulting in appropriately delivered ICD therapies (including antitachycardia pacing) or sustained ventricular tachyarrhythmia (>100/min, >30sek). (time frame: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.). 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 NCT02864771, 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 4 Jun 2020.