CardioSecur Trials

CardioSecur participates in clinical research with the overarching goal of reducing the burden of cardiovascular disease and improving disease management via innovative mobile ECG technology.

It is through our CardioSecur clinical trials program that we prove how CardioSecur:

Leads to earlier diagnosis of cardiac events
Allows for more precise localisation of cardiac events
Improves the efficiency of the diagnosis, management, and treatment of cardiovascular disease
Leads to health-economic benefits

Completed Trials

Ongoing Trials

Future Trials

Completed CardioSecur Trials

Validation Study: CardioSecur vs. Standard 12-lead ECG

Study Name: Comparison of Standard and Derived 12-lead Electrocardiograms Registrated by a Simplified 3-Lead Setting with Four Electrodes for Diagnosis of Coronary Angioplasty-Induced Myocardial Ischemia
Authors: Klaus Bonaventura, Ernst Wellenhofer and Eckart Fleck
Study Design: single centre, controlled
Goal: Validation of CardioSecur vs. standard 12-lead ECG
Results: >99% agreement between the two methods; 0 false negatives with CardioSecur, 100% concordance with respect to localisation of myocardial ischemia

Regular ECG recording in the monitoring of cardiovascular disease

Study Name: The Revealing timely ECG changes Decreases the likelihood of Undesirable Cardiac Events-Trial (REDUCE-Trial)
Authors: G van Langehnove, B Schwagten
Study Design: single centre, single-arm, non-randomized
Goal: Investigating the value of self-ECG monitoring with CardioSecur Active in the management of patients with cardiac conditions
Results: Regular ECG monitoring with CardioSecur Active led to 9.8% of patients being diagnosed with previously undiagnosed cardiac conditions (including ischemia and arrhythmias)

View paper.

Comparison Study: CardioSecur vs. EASI Bedside Monitor

Study Name: Comparative study of the CardioSecur pro ECG system with the EASI Philips M2601B
Authors: D Triebl, P Kenedi, I Preda, A Szekely, M Skribek, M Riemenschneider
Study Design: single centre, comparison, retrospective
Goal: Validation of CardioSecur’s technology vs. EASI M2601B
Results: Clinical diagnosis from both systems were identical in 100% of patients

Cardiac Prevention Study in Tennis Clubs

Study Name: The RHS Study: Screening Study for Recognition of Individual Risk for Heart Attack and Stroke
Authors: K Becker, T Wendt
Study Design: single centre, screening
Goal: Analysing individual risk of heart attack and/or of suffering from an embolic stroke due to atrial fibrillation.
Results: 61.8% (309/500 participants) were found to have abnormal results—13.6% had an increased risk of heart attack and 22.8% had abnormal ECG findings, with 3 participants being diagnosed with previously undiagnosed atrial fibrillation or flutter.

Evaluation of the Effect of Body Position on an ECG Recording

Study Name: Effect of Body Position on a Mobile, Vector-Derived, 12-Lead Electrocardiogram
Authors: P Kenedi, I Preda, J Thuer, A Szekely, M Skribek, D Triebl, A Abu Helous, M Riemenschneider
Study Design: single centre, retrospective
Goal: Assessment of impact of body position on the CardioSecur ECG reading
Results: No changes of statistical or clinical significance were detected with change in body position.

Ongoing CardioSecur Trials

Hamburg City Health Study: Population-based study for the detection of atrial fibrillation

Study Name/Concept: Hamburg City Health Study – CardioSecur EKG
Study location: Universitätsklinikum Hamburg-Eppendorf (Germany)
Design: monocentric, prospective, epidemiologic
Goal of study: Large population health study examining the relationship between environment, biology, genetics, and lifestyle on certain diseases—one of which is atrial fibrillation.
Current status: Data collection

CardioSecur in ambulances in the pre-hospital setting

Study Name/Concept: Evaluation of a new 4-electrode Device (CardioSecur) for preclinical ECG-Diagnosis
Study location: Universitätsklinikum Heidelberg (Germany)
Design: single centre, randomised, prospective
Goal of study: Evaluating the frequency of ST changes in the posterior leads V7-V9; evaluating the use of CardioSecur in the pre-hospital setting
Current status: Data evaluation

Effect of body position on the ECG recording

Study Name/Concept: Effect of body position on the CardioSecur ECG
Study location: Central Hospital of the Hungarian Defence Forces (Budapest, Hungary), Personal MedSystems GmbH
Design: single centre, comparison
Goal of study: Evaluation of the effect of body position (sitting, lying, standing) on the CardioSecur ECG reading
Current status: data evaluation

Comparison: CardioSecur vs. standard ECG during exercise

Study Name/Concept: Comparison of a vector-generated ECG with a standard ECG during a bicycle ergometer examination in patients with suspected relevant stenosing CAD
Study location: Dr. Reifart and Partners (Bad Soden, Germany)
Design: Single centre
Goal of study: evaluating the use of a vector-generated ECG for diagnosis of ischemia (using ST segment changes) during an exercise stress test
Current status: data collection

The use of CardioSecur for children

Study Name/Concept: Accuracy of the novel CardioSecur EKG with only 4 electrodes in comparison to a traditional 10-electrode EKG for use with children (4KIDS)
Study location: Stauferklinikum Schwäbisch Gmünd (Germany)
Design: single centre, comparison
Goal of study: Non-inferiority of CardioSecur Pro in comparison to a standard 12-lead ECG
Current status: Data evaluation

Detection and Localisation of Ischemia using CardioSecur’s Heart Map

Study Name/Concept: Comparing CardioSecur Pro with a standard 12-lead ECG in detecting cardiac ischemia
Study location: AZ Groeninge (Kortrijk, Belgium)
Design: single centre, prospective
Goal of study: Non-inferiority of CardioSecur’s ECG in detecting cardiac ischemia and proving added benefits of more ECG leads.
Current status: Data collection to start February 2018

Future CardioSecur Trials

As part of our „CardioSecur Trials“ program, we support investigator-initiated studies by providing our mobile ECG technology free of charge. Some topics of interest include: improving the efficiency of cardiac disease management, reducing cardiovascular disease burden, using smart data to establish correlations and predictive models, looking at the relationship between early diagnosis and health economics, and incorporating mHealth into current processes to improve patient care.

Interested in collaborating with us?

We are always open to partnering with clinicians and innovators to work with on new clinical trials!

Contact:

Markus Riemenschneider

+49 (0) 6990720130

Riemenschneider@cardiosecur.com