Cardiogoniometry for Early Diagnosis of Coronary Artery Disease Symptomatik

March 13, 2017 updated by: Stiftung Institut fuer Herzinfarktforschung

Cardiogoniometry Zur Früherkennung CAD Symptomatik

The register study CGM@CAD will examine whether cardiogoniometry can provide additional information concerning the indication for a diagnostic coronary angiography and if so, which additional value it has. Therefore, an additional cardiogoniometry will be carried out in consecutive patients who have been diagnosed with myocardial ischemia by means of established methods (exercise ECG, stress echocardiography, myocardial scintigraphy, or stress-MRT) and for whom an intracardiac catheter examination is regarded as indicated. The results of the different methods - particularly the results of the exercise ECG and the cardiogoniometry - will be checked against the results of the invasive examination as gold standard and the discharge diagnosis with regards to any correlation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

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

Description

Inclusion Criteria:

  • Indication for a coronary angiography
  • Age > 18 years
  • Patients written informed consent

Exclusion Criteria:

  • Patients with known CHD (condition after myocardial infarction and/or angio-graphically proven stenosis > 50% and/ or revascularization )
  • Patients with acute coronary syndrome
  • Patients with pace maker
  • Severe valvular heart defect
  • 50% extrasystole
  • Patients with dysrhythmia, which make a correct interpretation impossible (e.g. VES, bigeminies and other dysrhythmia with a high impact such as atrial extrasystoles)
  • Branch block
  • Atrial fibrillation

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients with stable angina pectoris
stable patients, who have been admitted to one of the participating centres for an elective coronary angiography
Procedure: cardiogoniometry
In the course of the project a cardiogoniometry will be carried out during the ambulant or residential hospitalization before the coronary angiography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
additional value of cardiogoniometry
Time Frame: at hospital admission
The protocol defines that the medical examination is to be preformed at hospital adimssion and again at discharge. Aim is to examine if cardiogoniometry can provide additional information for the decision to perform a diagnostic coronary angiography and if so, which additional value it has.
at hospital admission
additional value of cardiogoniometry
Time Frame: at hospital discharge
The protocol defines that the medical examination is to be preformed at hospital adimssion and again at discharge. Aim is to examine if cardiogoniometry can provide additional information for the decision to perform a diagnostic coronary angiography and if so, which additional value it has.
at hospital discharge

Collaborators and Investigators

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

Sponsor

Stiftung Institut fuer Herzinfarktforschung

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 (Actual)

December 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

June 7, 2010

First Submitted That Met QC Criteria

August 3, 2010

First Posted (Estimate)

August 4, 2010

Study Record Updates

Last Update Posted (Actual)

March 14, 2017

Last Update Submitted That Met QC Criteria

March 13, 2017

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGM@CAD

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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