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
About this trial
This is an interventional diagnostic trial for Stable Angina Pectoris focused on measuring cardiogoniometry, stable angina pectoris patients
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
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
NCT ID
NCT01174680
First Posted
June 7, 2010
Last Updated
March 13, 2017
Sponsor
Stiftung Institut fuer Herzinfarktforschung
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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