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Cardiogoniometry for Early Diagnosis of Coronary Artery Disease Symptomatik

Primary Purpose

Stable Angina Pectoris

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cardiogoniometry
Sponsored by
Stiftung Institut fuer Herzinfarktforschung
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stable Angina Pectoris focused on measuring cardiogoniometry, stable angina pectoris patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    patients with stable angina pectoris

    Arm Description

    stable patients, who have been admitted to one of the participating centres for an elective coronary angiography

    Outcomes

    Primary Outcome Measures

    additional value of cardiogoniometry
    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.
    additional value of cardiogoniometry
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 7, 2010
    Last Updated
    March 13, 2017
    Sponsor
    Stiftung Institut fuer Herzinfarktforschung
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01174680
    Brief Title
    Cardiogoniometry for Early Diagnosis of Coronary Artery Disease Symptomatik
    Official Title
    Cardiogoniometry Zur Früherkennung CAD Symptomatik
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2010 (Actual)
    Primary Completion Date
    February 2011 (Actual)
    Study Completion Date
    April 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Stiftung Institut fuer Herzinfarktforschung

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stable Angina Pectoris
    Keywords
    cardiogoniometry, stable angina pectoris patients

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    43 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    patients with stable angina pectoris
    Arm Type
    Experimental
    Arm Description
    stable patients, who have been admitted to one of the participating centres for an elective coronary angiography
    Intervention Type
    Procedure
    Intervention Name(s)
    cardiogoniometry
    Intervention Description
    In the course of the project a cardiogoniometry will be carried out during the ambulant or residential hospitalization before the coronary angiography.
    Primary Outcome Measure Information:
    Title
    additional value of cardiogoniometry
    Description
    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.
    Time Frame
    at hospital admission
    Title
    additional value of cardiogoniometry
    Description
    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.
    Time Frame
    at hospital discharge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Cardiogoniometry for Early Diagnosis of Coronary Artery Disease Symptomatik

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