Clinical 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 Clinical 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

thumbnail of 4 Electrodes – European Cardiology 2012 Bonaventura et al2

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

thumbnail of Poster_e-cardiology_V02_00

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.

thumbnail of “Effect of Body Position on a Mobile, Vector-Derived, 12-Lead Electrocardiogram

Ongoing Clinical Trials

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
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 Clinical 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

 

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