Follow-up of Kryptogenic Stroke Patients With Implantable vs. Non-invasive Devices to Detect Atrial Fibrillation. (TRACK-AF)

January 20, 2016 updated by: University Hospital Muenster

Prospective mono-center diagnostic study determining potential discrepancies in identifying atrial fibrillation by intraindividually comparing different types of follow-up strategies:

  1. How many stroke patients with atrial fibrillation are missed by standard stroke unit 24h- electrocardiography, and
  2. what is the effectiveness of the extended invasive and non-invasive ECG analysis tools to detect atrial fibrillation in stroke patients?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Atrial fibrillation often is paroxysmal and asymptomatic and, therefore, often not detected. Because atrial fibrillation is the leading risk factor for ischemic stroke, and oral anticoagulation is very efficacious for both primary and secondary stroke prevention in atrial fibrillation patients, detection of atrial fibrillation is essential to prevent stroke and stroke-induced disability and death. The incidence of atrial fibrillation and paroxysmal atrial fibrillation is particularly high in stroke patients. Short duration monitoring identified new atrial fibrillation in only about 5% to 10% of stroke patients. Estimates of missed paroxysmal atrial fibrillation in stroke patients go up to 40 000 patients in Germany per year.

Due to the known poor sensitivity of a 24h-ECG, all patients with stroke of unknown cause will undergo the above mentioned non-invasive and invasive ECG monitoring. Based on the data of these extended ECG-analyses, the rate of missed AF in conventionally diagnosed stroke unit patients could be determined by comparison to the 24h-ECG results. Additionally, a cost-benefit equation of the different ECG analysis tools will be calculated by comparison of the respective detection rates and the known follow-up costs.

Inclusion criteria: Patients years with acute ischemic stroke of unknown cause, monitored on a stroke unit undergoing routine diagnostic procedures (conventional 12-lead-ECG, 24h-ECG, echocardiography, cranial computed tomography or cranial magnetic resonance tomography, Transcranial Doppler and carotid duplex ultrasound, long-term blood pressure monitoring, standard laboratory investigations) Exclusion criteria: Stroke with known etiology, Stroke caused by intracranial hemorrhage

Diagnosis-as-usual:

- Standard 24h-ECG on stroke units according to existing guidelines

Investigational measure:

Non-invasive:

  • Online ECG analysis during the standardized stroke unit- monitoring
  • Ambulatory 7-day ECG monitoring

Invasive:

- atrial fibrillation detection by a permanently implantable direct cardiac rhythm monitor device in a period of up to 6 month

Duration of measures per patient:

2 weeks hospitalization, ~1 month rehabilitation, then implantation of the ECG device, and 6 months follow-up: 7.5 months in total

Primary outcome:

To determine the prevalence of undiagnosed AF in stroke patients undergoing the diagnostic standard (24h-ECG)

Secondary outcome:

Effectivity and cost-effectiveness ratios of the different ECG analyis tools

Description of the outcome:

Based on the obtained data, the prevalence of undiagnosed atrial fibrillation in stroke patients whom atrial fibrillation is missed by the standard diagnostic procedure (24h-ECG) will be determined by different extensive non-invasive and invasive ECG monitoring tools.

Additionally, following values of the applied ECG analysis tools will be calculated and compared:

  • Sensitivity: (true positives) / (true positives + false negatives)
  • Specificity: (true negatives) / (true negatives + false positives)
  • Positive predicted value: (true positives) / (true positives + false positives)
  • Negative predicted value: (true negatives) / (true negatives + false negatives)

Safety:

The implantable direct cardiac rhythm monitor device is an established and widely used diagnostic procedure in patients with unexplained syncope.

Study Type

Observational

Enrollment (Actual)

106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with stroke of unknown etiology

Description

Inclusion Criteria:

Patients years with acute ischemic stroke of unknown cause, monitored on a stroke unit undergoing routine diagnostic procedures (conventional 12-lead-ECG, 24h-ECG, echocardiography, cCT or cMRI, Transcranial Doppler and carotid duplex ultrasound, long-term blood pressure monitoring, standard laboratory investigations)

Exclusion Criteria:

  • Stroke with known etiology, Stroke caused by intracranial hemorrhage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the prevalence of undiagnosed AF in stroke patients undergoing the diagnostic standard (24h-ECG)
Time Frame: 7.5 months
Based on the obtained data, the prevalence (in percent) of undiagnosed AF in stroke patients whom AF is missed by the standard diagnostic procedure (24h-ECG) will be determined by different extensive non-invasive and invasive ECG monitoring tools
7.5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of the automated software based ECG analysis in comparison to the "gold-standard" the implanted cardiac monitor
Time Frame: 7.5 months
The Sensitivity (in percent), the Specificity (in percent), the positive predictive value (in percent) and the negative predictive value (in percent) will be calculated for the automated ECG software analysis in comparison to the "gold-standard" the implanted cardiac monitor
7.5 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of the automated software based ECG analysis in comparison to the standard methods (routine ECG, 24h longterm ECG)
Time Frame: 7.5 months
The Sensitivity (in percent), the Specificity (in percent), the positive predictive value (in percent) and the negative predictive value (in percent) will be calculated for the automated ECG software analysis in comparison to the actual diagnostic standard the routinely performed ECG+longterm ECG.
7.5 months
Cost efficacy of the different methods (automated software based ECG analysis and implantable cardiac monitor)
Time Frame: 7.5 months

The data can be helpful to increase the cost efficacy. There are 3 hypotheses. 1.) The software analysis is reliable enough to detect AF than an implantable device is no longer needed.

2.) The software analysis is unreliable 3.) The software analysis has a high negative predictive value and can provide as a preselection tool. Patients with probable AF calculated by the software analysis have a higher profit by the implantation than the patient with no AF calculated by the software.
7.5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Collaborators

European Union

Investigators

  • Principal Investigator: Dittrich Ralf, MD, Department of Neurology, University of Muenster

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

December 22, 2015

First Submitted That Met QC Criteria

December 22, 2015

First Posted (Estimate)

December 29, 2015

Study Record Updates

Last Update Posted (Estimate)

January 21, 2016

Last Update Submitted That Met QC Criteria

January 20, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRACK-AF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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