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Cardiogoniometry for Early Diagnosis of Coronary Artery Disease Symptomatik

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Stiftung Institut fuer Herzinfarktforschung.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier:
NCT01174680
First received: June 7, 2010
Last updated: August 3, 2010
Last verified: August 2010
History of Changes
  Purpose

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.


Condition Intervention
Stable Angina Pectoris
 Procedure: cardiogoniometry

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Cardiogoniometry Zur Früherkennung CAD Symptomatik

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stiftung Institut fuer Herzinfarktforschung:

Primary Outcome Measures:
  • additional value of cardiogoniometry [ Time Frame: at hospital admission ] [ Designated as safety issue: No ]
    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 [ Time Frame: at hospital discharge ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 460
Study Start Date: December 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01174680

Contacts
Contact: Jochen Senges, Prof 0049 621 503 ext 2801 senges@herzinfarktforschung.de

Sponsors and Collaborators
Stiftung Institut fuer Herzinfarktforschung
  More Information

No publications provided

Responsible Party: Prof Senges, Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier: NCT01174680     History of Changes
Other Study ID Numbers: CGM@CAD
Study First Received: June 7, 2010
Last Updated: August 3, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by Stiftung Institut fuer Herzinfarktforschung:
cardiogoniometry
stable angina pectoris patients

Additional relevant MeSH terms:
Angina Pectoris
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
 Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on May 23, 2013