AF Stroke Substudy SL-ECG Versus 12lead ECG

NCT03715361

Last updated date
Study Location
Uniklinium RWTH Aachen
Aachen, North-Rhine-Westphalia, 52074, Germany
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
ECG, Atrial Fibrillation, ECG Hand-held Diagnostic Tool
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patient is 18 years old, for minors the signature of the legal guardian is required.

- Understanding of the essence, meaning and scope of the study.

- Patients (in-/outpatient) who receive a 12lead ECG through Medical Clinic 1.

- Volunteers who are willing to have a 12lead ECG and an SL-ECG performed and provide medical information.

- Signed informed consent

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Insufficient language skills


- Limited cognitive abilities


- Limited physical abilities (i.e. tremor)

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ECG, Atrial Fibrillation, ECG Hand-held Diagnostic ToolAF Stroke Substudy SL-ECG Versus 12lead ECG
NCT03715361
  1. Aachen, North-Rhine-Westphalia
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title AF Stroke Substudy SL-ECG Versus 12lead ECG
Official Title AF Stroke Substudy SL-ECG Versus 12lead ECG
Brief Summary The purpose of the study is to compare parameters obtained per SL-ECG with the values from 12lead-ECG measurement. Patients who undergo out- or inpatient treatment and who receive a 12lead-ECG are asked to participate in this examination. Furthermore, 50 patients without heart disease should be included (control group).
Detailed Description

Atrial fibrillation is the most common cardiac arrhythmia in Germany. Clinical studies have shown that atrial fibrillation is associated with increased morbidity and mortality and reduced quality of life. Patients with atrial fibrillation have a three times higher risk of heart failure and a four to five times higher risk of ischemic stroke. In addition to these risks, atrial fibrillation is often asymptomatic and therefore more difficult to diagnose. It is estimated that about one third of all atrial fibrillation patients are asymptomatic.

For this reason, the study "Opportunistic Screening in Pharmacies for Atrial Fibrillation in Seniors" was conducted in Aachen. Within four weeks more than 7000 volunteers could be measured in participating pharmacies using a ECG hand-held diagnostic tool. Since the already measured subjects only have the SL-ECG measurement of the hand-held diagnostic tool, the aim of this substudy is to establish a reference group. In this reference group a 12lead-ECG is performed by routine ECG and a SL-ECG measurement by ECG hand-held diagnostic tool. The aim of the study is to compare the measured parameters and to optimize the algorithm to evaluate the remaining SL-ECGs of the main study.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients and volunteers that meets the inclusion criteria and are not affected by the exclusion criteria are allowed to participate in this study.
Condition
  • ECG
  • Atrial Fibrillation
  • ECG Hand-held Diagnostic Tool
Intervention Diagnostic Test: SL-ECG
additional SL-ECG measurement
Study Groups/Cohorts
  • Patients
    Patients (500 patients ? ) who undergo out- or inpatient treatment and who did a 12lead-ECG measurement, repeat the procedure using the hand-held diagnostic tool (SL-ECG).
    Intervention: Diagnostic Test: SL-ECG
  • Control Group
    Fifty volunteers who did a 12lead-ECG measurement, repeat the procedure using the hand-held diagnostic tool (SL-ECG).
    Intervention: Diagnostic Test: SL-ECG
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 18, 2018)
550
Original Estimated Enrollment Same as current
Actual Study Completion Date March 26, 2019
Actual Primary Completion Date March 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient is 18 years old, for minors the signature of the legal guardian is required.
  • Understanding of the essence, meaning and scope of the study.
  • Patients (in-/outpatient) who receive a 12lead ECG through Medical Clinic 1.
  • Volunteers who are willing to have a 12lead ECG and an SL-ECG performed and provide medical information.
  • Signed informed consent

Exclusion Criteria:

  • Insufficient language skills
  • Limited cognitive abilities
  • Limited physical abilities (i.e. tremor)
Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03715361
Other Study ID Numbers 18-078
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party RWTH Aachen University
Study Sponsor RWTH Aachen University
Collaborators Pfizer
Investigators
Principal Investigator:Nikolaus MarxHead of the Clinic for Cardiology, Pneumology, Angiology and Internal Intensive Medicine
PRS Account RWTH Aachen University
Verification Date March 2020