NCT01174680

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2010

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 4, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

March 14, 2017

Status Verified

August 1, 2010

Enrollment Period

2 months

First QC Date

June 7, 2010

Last Update Submit

March 13, 2017

Conditions

Keywords

cardiogoniometrystable angina pectoris patients

Outcome Measures

Primary Outcomes (2)

  • 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.

    at hospital admission

  • 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.

    at hospital discharge

Study Arms (1)

patients with stable angina pectoris

EXPERIMENTAL

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

Procedure: cardiogoniometry

Interventions

In the course of the project a cardiogoniometry will be carried out during the ambulant or residential hospitalization before the coronary angiography.

patients with stable angina pectoris

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • % 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Angina, Stable

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

June 7, 2010

First Posted

August 4, 2010

Study Start

December 1, 2010

Primary Completion

February 1, 2011

Study Completion

April 1, 2011

Last Updated

March 14, 2017

Record last verified: 2010-08