Myocardial InfarctionSMART-MINCT02594488
Implantable Cardiac Monitors in High-Risk Post-Infarction Patients With Cardiac Autonomic Dysfunction
A study testing Medtronic Reveal LINQ implantable cardiac monitor in people with Myocardial Infarction and Autonomic Nervous System Diseases, run by LMU Klinikum at 32 sites in 2 countries.
Trial summary
The majority of deaths after myocardial infarction occurs in patients with preserved left ventricular ejection fraction (>35%) for whom no prophylactic strategies exist. Periodic Repolarization Dynamics (PRD) and Deceleration Capacity (DC) of heart rate are autonomic risk markers that identify a new high risk group of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Infarction, Autonomic Nervous System Diseases
- What is being tested?
- Medtronic Reveal LINQ implantable cardiac monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 32 sitesin 2 countries
- Study dates
- 6 May 2016to Feb 2021
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute myocardial infarction <40 days
- Left ventricular ejection fraction 36-50%
- Presence of cardiac autonomic dysfunction by means of abnormal periodic repolarization dynamics and/or abnormal deceleration capacity
- Age 18-80 years
- Sinus rhythm
- Optimal medical therapy
Who cannot join
- ICD or pacemaker indication
- Known paroxysmal or persistent atrial fibrillation
- Life expectancy < 12 months
- Inability to comply with follow-up
- Pregnancy
- Participation in another trial that may interfere
Trial locations and contacts
32 sites in 2 countries.
32 sites in 2 countries
Germany31 sites
Universtitätsklinikum der RWTH Aachen, Medizinische Klinik I
Aachen, 52074
Universitätsmedizin Berlin, Klinik für Kardiologie, Charite, Campus Benjamin Franklin
Berlin, 12200
Universitätsmedizin Berlin, Klinik für Kardiologie, Charite, Campus Virchow Kinikum
Berlin, 13353
Klinik Höhenried, Rehabilitationszentrum am Starnberger See
Bernried, 82347
Herzzentrum Dresden, Univeristätsklinik an der TU Dresden
Dresden, 01307
Universitätklinikum Essen, Klinik für Kardiologie und Angiologie
Essen, 45122
Kliniken Ostallgäu-Kaufbeuren, Klinik Füssen
Füssen, 87629
Universitätsmedizin Göttingen, Klinikum für Kardiologie und Pneumologie
Göttingen
Universitätsmedizin Greifswald, Klinik für Innere Medizin B
Greifswald, 17475
Asklepios Klinik St. Georg, Abteilung für Kardiologie
Hamburg, 20099
Universitäres Herzzentrum Hamburg GmbH
Hamburg, 20251
Universitätsklinikum Heidelberg
Heidelberg, 69120
Universitätsklinikum des Saarlandes, Medizinische Klinik III
Homburg, Saarland, 66421
Städtisches Klinikum Karlsruhe, Medizinische Klinik IV
Karlsruhe, Baden-Wurttemberg, 76133
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Innere Medizin III
Kiel, 24105
Universitätsklinikum Leipzig
Leipzig, 04103
Leipzig Heart Institute GmbH
Leipzig, 04289
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Medizinische Klinik II
Lübeck, 23538
Universitätsmedizin Mainz
Mainz, 55131
Universitätsklinikum Mannheim
Mannheim, 68167
Technische Universität München, Medizinische Klinik und Poliklinik I
München, Bavaria, 81675
Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen
München, 80636
Klinikum Neuperlach, Städtisches Klinikum München GmbH
München, 81737
Klinikum der Universität München
Munich, Bavaria, 81377
Universitätsklinikum Münster
Münster, 48149
Universitätsklinik der Paracelsus Medizinischen Privatuniversität, Klinikum Nürnberg
Nuremberg, 90471
Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin II
Regensburg, Bavaria, 93053
Universitätsklinikum Tübingen, Medizinische Klinik III
Tübingen, Baden-Wurttemberg, 72076
Kliniken Nordoberpfalz AG, Klinikum Weiden
Weiden, 92637
St. Josefs-Hospital Wiesbaden
Wiesbaden, 65189
HELIOS Herzzentrum Wuppertal, Klinik für Kardiologie
Wuppertal, North Rhine-Westphalia, 42117
Austria1 site
Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin III
Innsbruck, 6020
About this study
Official title: Implantable Cardiac Monitors in High-risk Post-infarction Patients With Cardiac Autonomic Dysfunction and Moderately Reduced Left Ventricular Ejection Fraction
The majority of deaths after myocardial infarction occurs in patients with preserved left ventricular ejection fraction (>35%) for whom no prophylactic strategies exist. Periodic Repolarization Dynamics (PRD) and Deceleration Capacity (DC) of heart rate are autonomic risk markers that identify a new high risk group of patients with LVEF 35-50% who have the same poor prognosis as patients with LVEF ≤35%.
In SMART-MI, post-infarction patients with LVEF 35-50% and abnormal PRD and/or DC will be randomly assigned to biomonitoring-guided therapy or conventional follow-up.
Read the detailed description
Sudden cardiac death (SCD) is the most common single cause of death in the industrialized world. Patients after myocardial infarction (MI) are at increased risk of SCD. Current guidelines recommend prophylactic ICD-implantation in post-MI patients with reduced left ventricular ejection fraction (LVEF ≤35%). However, the majority of arrhythmic deaths after MI occurs in patients with LVEF >35% in whom no specific prophylactic strategies exist, indicating an important unmet medical need.
There is a large body of evidence that presence of cardiac autonomic dysfunction after MI is associated with an increased susceptibility to malignant brady- and tachyarrhythmias eventually culminating in SCD. Periodic repolarization dynamics (PRD) and heart rate deceleration capacity (DC) are clinically validated autonomic risk markers that provide strong and independent prognostic information in post-MI patients with LVEF >35%. PRD and DC reflect different facets of autonomic function and can therefore be used in combination to predict risk. Previous studies demonstrated that combined assessment of PRD and DC identifies a new high-risk group among post-MI patients with moderately reduced LVEF (36-50%). This new high-risk group has similar characteristics with respect to prognosis and patient numbers as the established high-risk group identified by LVEF ≤35%.
However, the exact mechanisms leading to death in this new high-risk group need to be investigated in order to develop specific preventive strategies. As known from studies with implantable cardiac monitors (ICM) in post-MI patients with LVEF ≤40% eventual death is often preceded by primarily asymptomatic serious arrhythmic events. These data suggest a potential time frame for pre-emptive interventions in case of arrhythmic events, which could improve outcome.
Therefore, SMART-MI will assess the occurrence and prognostic implications of serious arrhythmic events in this newly identified high-risk group by remote monitoring with ICM. Survivors of acute MI (<40 days) and LVEF 36-50% undergo autonomic testing for presence of abnormal PRD and/or DC. Those with autonomic dysfunction will be randomly assigned to ICM-implantation or conventional follow-up. Superiority of ICMs in detection of predefined serious arrhythmic events will be tested based on a time-to-event analysis. A central ICM core lab will be implemented allowing for a response to arrhythmias within 48h. The effect of remote monitoring on clinical outcomes will be tested as secondary endpoints. The study will provide the rationale for a future guideline-relevant study testing prophylactic therapies in this newly identified high-risk group.
- Being tested
- Medtronic Reveal LINQ implantable cardiac monitor
- Keywords
- Myocardial infarction, Autonomic nervous system, Risk stratification, Implantable cardiac monitor, Sudden cardiac death, ECG
- Medical subject headings
- Myocardial Infarction, Autonomic Nervous System Diseases, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Reveal LINQ implantable cardiac monitorDevice
The implantable cardiac monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. Predefined arrhythmias are daily transmitted to a central core lab. In case of arrhythmias, specific guideline-based treatment is initiated within 48h.
| Study group | Role | What they receive |
|---|---|---|
| Remote monitoring | Active comparator | Remote cardiac monitoring by the Reveal® LINQ implantable cardiac monitor Receives: Device: Medtronic Reveal LINQ implantable cardiac monitor |
| Control arm | No intervention | Follow-up at the same frequency, but with no implantable cardiac monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of serious arrhythmic events
Time to detection of one of the following serious arrhythmic events: atrial fibrillation ≥6 min, higher degree AV-block ≥ IIb, ventricular tachycardia with a cycle length ≤320ms lasting for ≥12 sec (corresponding to 40 beats), sustained ventricular tachycardia and ventricular fibrillation
Measured: 18 months
Secondary outcomes (9)
Composite of all-cause mortality, stroke, systemic arterial thromboembolism and unplanned hospitalizations for decompensated heart failure
Time to one of following clinical events: death, stroke, systemic arterial thromboembolism and unplanned hospitalization for decompensated heart failure
Measured: 18 months
All cause mortality
Time to death
Measured: 18 months
Cardiovascular mortality
Time to cardiovascular death
Measured: 18 months
Unplanned hospitalizations for decompensated heart failure
Time to unplanned hospitalizations for decompensated heart failure
Measured: 18 months
Sinus arrest >6sec
Time to detection of sinus arrest >6sec
Measured: 18 months
Atrial fibrillation ≥6 min
Time to detection of atrial fibrillation ≥6 min
Measured: 18 months
Higher degree AV-block ≥ IIb
Time to detection of higher degree AV-block ≥ IIb
Measured: 18 months
Non-sustained ventricular tachycardia
Time to detection of ventricular tachycardia with a cycle length ≤320ms lasting for ≥12 sec
Measured: 18 months
Sustained ventricular tachycardia / ventricular fibrillation
Time to detection of sustained ventricular tachycardia / ventricular fibrillation
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study start6 May 2016
- Primary completionFeb 2021
- Study completionFeb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Medtronic Cardiac Rhythm and Heart Failure
- Responsible party
- Principal investigator, Axel Bauer, LMU Klinikum
- Investigators
- Axel Bauer, MD, Principal investigator, LMU KlinikumStefan Kaeaeb, MD, Principal investigator, LMU KlinikumSteffen Massberg, MD, Study chair, LMU Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594488
- Sponsor's protocol ID
- 118-15
- Acronym
- SMART-MI
- Status last verified
- Jun 2021
- First submitted
- 31 Oct 2015
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rizas KD, Nieminen T, Barthel P, Zurn CS, Kahonen M, Viik J, Lehtimaki T, Nikus K, Eick C, Greiner TO, Wendel HP, Seizer P, Schreieck J, Gawaz M, Schmidt G, Bauer A. Sympathetic activity-associated periodic repolarization dynamics predict mortality following myocardial infarction. J Clin Invest. 2014 Apr;124(4):1770-80. doi: 10.1172/JCI70085. Epub 2014 Mar 18.
PubMed 24642467Bauer A, Kantelhardt JW, Barthel P, Schneider R, Makikallio T, Ulm K, Hnatkova K, Schomig A, Huikuri H, Bunde A, Malik M, Schmidt G. Deceleration capacity of heart rate as a predictor of mortality after myocardial infarction: cohort study. Lancet. 2006 May 20;367(9523):1674-81. doi: 10.1016/S0140-6736(06)68735-7.
PubMed 16714188Bauer A, Sappler N, von Stulpnagel L, Klemm M, Schreinlechner M, Wenner F, Schier J, Al Tawil A, Dolejsi T, Krasniqi A, Eiffener E, Bongarth C, Stuhlinger M, Huemer M, Gori T, Wakili R, Sahin R, Schwinger R, Lutz M, Luik A, Gessler N, Clemmensen P, Linke A, Maier LS, Hinterseer M, Busch MC, Blaschke F, Sack S, Lennerz C, Licka M, Tilz RR, Ukena C, Ehrlich JR, Zabel M, Schmidt G, Mansmann U, Kaab S, Rizas KD, Massberg S; SMART-MI-DZHK9 investigators. Telemedical cardiac risk assessment by implantable cardiac monitors in patients after myocardial infarction with autonomic dysfunction (SMART-MI-DZHK9): a prospective investigator-initiated, randomised, multicentre, open-label, diagnostic trial. Lancet Digit Health. 2022 Feb;4(2):e105-e116. doi: 10.1016/S2589-7500(21)00253-3.
PubMed 35090674Hamm W, Rizas KD, Stulpnagel LV, Vdovin N, Massberg S, Kaab S, Bauer A. Implantable cardiac monitors in high-risk post-infarction patients with cardiac autonomic dysfunction and moderately reduced left ventricular ejection fraction: Design and rationale of the SMART-MI trial. Am Heart J. 2017 Aug;190:34-39. doi: 10.1016/j.ahj.2017.05.006. Epub 2017 May 19.
PubMed 28760211Rizas KD, Hamm W, Kaab S, Schmidt G, Bauer A. Periodic Repolarisation Dynamics: A Natural Probe of the Ventricular Response to Sympathetic Activation. Arrhythm Electrophysiol Rev. 2016 May;5(1):31-6. doi: 10.15420/aer.2015:30:2.
PubMed 27403291
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantable Cardiac Monitors in High-risk Post-infarction Patients With Cardiac Autonomic Dysfunction and Moderately Reduced Left Ventricular Ejection Fraction
- ClinicalTrials.gov ID
- NCT02594488
- Acronym / sponsor ID
- SMART-MI / 118-15
- Keywords
- Myocardial infarction, Autonomic nervous system, Risk stratification, Implantable cardiac monitor, Sudden cardiac death, ECG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Collaborators
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Medtronic Cardiac Rhythm and Heart Failure
- Study start
- 6 May 2016 (actual)
- Primary completion
- Feb 2021 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 3 Nov 2015 (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 majority of deaths after myocardial infarction occurs in patients with preserved left ventricular ejection fraction (>35%) for whom no prophylactic strategies exist. Periodic Repolarization Dynamics (PRD) and Deceleration Capacity (DC) of heart rate are autonomic risk markers that identify a new high risk group of patients with LVEF 35-50% who have the same poor prognosis as patients with LVEF ≤35%.
In SMART-MI, post-infarction patients with LVEF 35-50% and abnormal PRD and/or DC will be randomly assigned to biomonitoring-guided therapy or conventional follow-up.
Detailed description
Sudden cardiac death (SCD) is the most common single cause of death in the industrialized world. Patients after myocardial infarction (MI) are at increased risk of SCD. Current guidelines recommend prophylactic ICD-implantation in post-MI patients with reduced left ventricular ejection fraction (LVEF ≤35%). However, the majority of arrhythmic deaths after MI occurs in patients with LVEF >35% in whom no specific prophylactic strategies exist, indicating an important unmet medical need.
There is a large body of evidence that presence of cardiac autonomic dysfunction after MI is associated with an increased susceptibility to malignant brady- and tachyarrhythmias eventually culminating in SCD. Periodic repolarization dynamics (PRD) and heart rate deceleration capacity (DC) are clinically validated autonomic risk markers that provide strong and independent prognostic information in post-MI patients with LVEF >35%. PRD and DC reflect different facets of autonomic function and can therefore be used in combination to predict risk. Previous studies demonstrated that combined assessment of PRD and DC identifies a new high-risk group among post-MI patients with moderately reduced LVEF (36-50%). This new high-risk group has similar characteristics with respect to prognosis and patient numbers as the established high-risk group identified by LVEF ≤35%.
However, the exact mechanisms leading to death in this new high-risk group need to be investigated in order to develop specific preventive strategies. As known from studies with implantable cardiac monitors (ICM) in post-MI patients with LVEF ≤40% eventual death is often preceded by primarily asymptomatic serious arrhythmic events. These data suggest a potential time frame for pre-emptive interventions in case of arrhythmic events, which could improve outcome.
Therefore, SMART-MI will assess the occurrence and prognostic implications of serious arrhythmic events in this newly identified high-risk group by remote monitoring with ICM. Survivors of acute MI (<40 days) and LVEF 36-50% undergo autonomic testing for presence of abnormal PRD and/or DC. Those with autonomic dysfunction will be randomly assigned to ICM-implantation or conventional follow-up. Superiority of ICMs in detection of predefined serious arrhythmic events will be tested based on a time-to-event analysis. A central ICM core lab will be implemented allowing for a response to arrhythmias within 48h. The effect of remote monitoring on clinical outcomes will be tested as secondary endpoints. The study will provide the rationale for a future guideline-relevant study testing prophylactic therapies in this newly identified high-risk group.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote monitoring | Active comparator | Device: Medtronic Reveal LINQ implantable cardiac monitorRemote cardiac monitoring by the Reveal® LINQ implantable cardiac monitor |
| Control arm | No intervention | –Follow-up at the same frequency, but with no implantable cardiac monitor |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Acute myocardial infarction <40 days
- Left ventricular ejection fraction 36-50%
- Presence of cardiac autonomic dysfunction by means of abnormal periodic repolarization dynamics and/or abnormal deceleration capacity
- Age 18-80 years
- Sinus rhythm
Key exclusion criteria (6 listed)
- ICD or pacemaker indication
- Known paroxysmal or persistent atrial fibrillation
- Life expectancy < 12 months
- Inability to comply with follow-up
- Pregnancy
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 |
|---|---|---|
| Medtronic Reveal LINQ implantable cardiac monitorThe implantable cardiac monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. Predefined arrhythmias are daily transmitted to a central core lab. In case of arrhythmias, specific guideline-based treatment is initiated within 48h. | Device | Remote monitoring |
Primary outcome
Detection of serious arrhythmic events
Time frame: 18 months
Time to detection of one of the following serious arrhythmic events: atrial fibrillation ≥6 min, higher degree AV-block ≥ IIb, ventricular tachycardia with a cycle length ≤320ms lasting for ≥12 sec (corresponding to 40 beats), sustained ventricular tachycardia and ventricular fibrillation
9 secondary outcomes
Composite of all-cause mortality, stroke, systemic arterial thromboembolism and unplanned hospitalizations for decompensated heart failure
Time frame: 18 months
All cause mortality
Time frame: 18 months
Cardiovascular mortality
Time frame: 18 months
Unplanned hospitalizations for decompensated heart failure
Time frame: 18 months
Sinus arrest >6sec
Time frame: 18 months
Atrial fibrillation ≥6 min
Time frame: 18 months
Higher degree AV-block ≥ IIb
Time frame: 18 months
Non-sustained ventricular tachycardia
Time frame: 18 months
Sustained ventricular tachycardia / ventricular fibrillation
Time frame: 18 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 23 Jun 2021.
- Background: PubMed 24642467Rizas KD, Nieminen T, Barthel P, Zurn CS, Kahonen M, Viik J, Lehtimaki T, Nikus K, Eick C, Greiner TO, Wendel HP, Seizer P, Schreieck J, Gawaz M, Schmidt G, Bauer A. Sympathetic activity-associated periodic repolarization dynamics predict mortality following myocardial infarction. J Clin Invest. 2014 Apr;124(4):1770-80. doi: 10.1172/JCI70085. Epub 2014 Mar 18.
- Background: PubMed 16714188Bauer A, Kantelhardt JW, Barthel P, Schneider R, Makikallio T, Ulm K, Hnatkova K, Schomig A, Huikuri H, Bunde A, Malik M, Schmidt G. Deceleration capacity of heart rate as a predictor of mortality after myocardial infarction: cohort study. Lancet. 2006 May 20;367(9523):1674-81. doi: 10.1016/S0140-6736(06)68735-7.
- Derived from this study: PubMed 35090674Bauer A, Sappler N, von Stulpnagel L, Klemm M, Schreinlechner M, Wenner F, Schier J, Al Tawil A, Dolejsi T, Krasniqi A, Eiffener E, Bongarth C, Stuhlinger M, Huemer M, Gori T, Wakili R, Sahin R, Schwinger R, Lutz M, Luik A, Gessler N, Clemmensen P, Linke A, Maier LS, Hinterseer M, Busch MC, Blaschke F, Sack S, Lennerz C, Licka M, Tilz RR, Ukena C, Ehrlich JR, Zabel M, Schmidt G, Mansmann U, Kaab S, Rizas KD, Massberg S; SMART-MI-DZHK9 investigators. Telemedical cardiac risk assessment by implantable cardiac monitors in patients after myocardial infarction with autonomic dysfunction (SMART-MI-DZHK9): a prospective investigator-initiated, randomised, multicentre, open-label, diagnostic trial. Lancet Digit Health. 2022 Feb;4(2):e105-e116. doi: 10.1016/S2589-7500(21)00253-3.
- Derived from this study: PubMed 28760211Hamm W, Rizas KD, Stulpnagel LV, Vdovin N, Massberg S, Kaab S, Bauer A. Implantable cardiac monitors in high-risk post-infarction patients with cardiac autonomic dysfunction and moderately reduced left ventricular ejection fraction: Design and rationale of the SMART-MI trial. Am Heart J. 2017 Aug;190:34-39. doi: 10.1016/j.ahj.2017.05.006. Epub 2017 May 19.
- Derived from this study: PubMed 27403291Rizas KD, Hamm W, Kaab S, Schmidt G, Bauer A. Periodic Repolarisation Dynamics: A Natural Probe of the Ventricular Response to Sympathetic Activation. Arrhythm Electrophysiol Rev. 2016 May;5(1):31-6. doi: 10.15420/aer.2015:30:2.
- Deutsches Zentrum für HerzkreislaufforschungLink provided by the sponsor.
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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.
Axel Bauer, MD principal investigator
LMU Klinikum
Stefan Kaeaeb, MD principal investigator
LMU Klinikum
Steffen Massberg, MD study chair
LMU Klinikum
32 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Reveal LINQ implantable cardiac monitor in people with Myocardial Infarction and Autonomic Nervous System Diseases, run by LMU Klinikum at 32 sites in 2 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 6 inclusion and 6 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 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Germany, 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?
Detection of serious arrhythmic events (time frame: 18 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 NCT02594488, which also lists 5 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 23 Jun 2021.