Heart Cycle Prestudy

NCT01627457 | Completed

• 1 other identifier: 11-094
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

In this Prestudy which will be followed by the multicentral GEx- main-trial, the feasibility of a new cardiac rehabilitation device (GEx system) is proved with coronary heart disease patients who participate in cardiac rehabilitation training exercise at the rehabilitation clinic (phase II) and subsequently at home (phase III). The GEx system consists of a easy-to-wear vest with integrated electrodes to measure electrocardiogram (ECG), respiration and activity, furthermore of a PDA to collect and store the monitored data and a cradle to charge the batteries. Several physiological parameters are extracted from thes measured vital signs like heart rate, breathing rate, ECG and activity. In this pretrial first the GEx sensor system is validated during guided exercise of the patients in the rehabilitation clinic (phase II). Subsequently at home (phase III) the practicability of the vest and sensors and possible technical problems in real- life use are proved. This means after moderate training like walking, cycling or running at home for 3 weeks patients will report the feasibility of usage. The ECG data and breathing- frequency data will be analyzed to see if data are recorded and transmitted well in regard to technical problems.

Conditions

Coronary Artery Disease; Acute Myocardial Infarction

Keywords

Coronary Artery Disease; Guided Exercise System including ECG Vest with vital signs sensors and PDA; Validation Telemedical Device in regard to accuracy and safety of data; Homely Rehabilitation; Practicability and technical problems at home

Outcome Measures

Primary Outcomes (1)

• Evaluation of accuracy and safety of data of the GEx system received during in-patient cardiac rehabilitation (phase II) and evaluation of practicability and technical problems in real- life use during cardiac rehabilitation at home (phase III).

  The GEx system is evaluated during in-patient cardiac rehabilitation supervised by cardiologists in order to analyze data for quality of heart rate measurement and data acquisition by device. 30 Patients undergo moderate training exercise like walking, cycling or running three times a week three weeks long. In a second step practicability and technical problems are tested during continuation of the moderate training of the patient at home. The Evaluation is performed by CPX, lactate measurement, 2D-Echo, questionnaires and device data like heart rate and breathing rate.

  6 Months

Study Arms (1)

GEx Training

EXPERIMENTAL

CAD Patients in cardiac rehabilitation phase II (inpatient) and phase III (at home)in order to analyze data for quality of heart rate measurement and data acquisition by device as well as for practicability and technical problems at home.

Device: Guided Exercise (GEx) system

Interventions

Guided Exercise (GEx) system DEVICE

30 CAD patients will wear the GEx system while they are trained during inpatient cardiac rehabilitation (phase II) in order to evaluate accuracy and safety of data like heart rate, breathing, ECG three times a week for about three weeks. In a second step these patients train at home (phase III) in order to evaluate practicability and technical problems of the GEx device three times a week for about three weeks.

GEx Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients suffering from CAD and presenting after an acute myocardial infarction or elective coronary intervention
• Patients willing to exercise
• With a preference for walking/ cycling/ running
• Eligible for the normal local rehabilitation program
• Contractually capable and mentally able to understand and follow the instructions of the study personnel
• Able to give informed consent

You may not qualify if:

• Ejection Fraction at discharge from hospital \< 30%
• Unwillingness or lack of capability to handle the device
• Unable to perform exercise
• Severe congestive heart failure NYHA III/IV
• Severe valve disease without replacement
• Slow healing wounds
• Women who are pregnant or breastfeeding
• Refusal of device

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

Medical Clinic I, University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease; Ductus Arteriosus, Patent

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Patrick Schauerte, Professor MD

  University Hospital Aachen, Department of Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2012
• First Posted: June 25, 2012
• Study Start: September 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: November 27, 2013

Record last verified: 2013-11

Locations

DE (1)