Stable Angina PectorisNCT01174680
Cardiogoniometry for Early Diagnosis of Coronary Artery Disease Symptomatik
A study testing cardiogoniometry in people with Stable Angina Pectoris, run by Stiftung Institut fuer Herzinfarktforschung.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Angina Pectoris
- What is being tested?
- cardiogoniometry
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for a coronary angiography
- Age > 18 years
- Patients written informed consent
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Stable Angina Pectoris
- Being tested
- cardiogoniometry
- Keywords
- cardiogoniometry, stable angina pectoris patients
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiogoniometryProcedure or surgery
In the course of the project a cardiogoniometry will be carried out during the ambulant or residential hospitalization before the coronary angiography.
| Study group | Role | What they receive |
|---|---|---|
| patients with stable angina pectoris | Experimental | stable patients, who have been admitted to one of the participating centres for an elective coronary angiography Receives: Procedure: cardiogoniometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: at hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2010 (estimated)
- Study startDec 2010
- Primary completionFeb 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable Angina PectorisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiftung Institut fuer Herzinfarktforschung
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174680
- Sponsor's protocol ID
- CGM@CAD
- Status last verified
- Aug 2010
- First submitted
- 7 Jun 2010
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiogoniometry Zur Früherkennung CAD Symptomatik
- ClinicalTrials.gov ID
- NCT01174680
- Acronym / sponsor ID
- CGM@CAD
- Conditions
- Stable Angina Pectoris
- Keywords
- cardiogoniometry, stable angina pectoris patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Stiftung Institut fuer HerzinfarktforschungUniversity, hospital or other
- Study start
- Dec 2010 (actual)
- Primary completion
- Feb 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 4 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with stable angina pectoris | Experimental | Procedure: cardiogoniometrystable patients, who have been admitted to one of the participating centres for an elective coronary angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indication for a coronary angiography
- Age > 18 years
- Patients written informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiogoniometryIn the course of the project a cardiogoniometry will be carried out during the ambulant or residential hospitalization before the coronary angiography. | Procedure or surgery | patients with stable angina pectoris |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing cardiogoniometry in people with Stable Angina Pectoris, run by Stiftung Institut fuer Herzinfarktforschung.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
additional value of cardiogoniometry (time frame: at hospital admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2017.