Angina PectorisNCT01389674
Hybrid Intraprocedural Imaging Based on 2 Different Imaging Methods
A study testing 2D-strain echo in people with Angina Pectoris and Left Ventricular Wall Motion Abnormalities, run by RWTH Aachen University at 1 site in Germany.
Trial summary
The investigators will check the feasibility of an intraprocedural vitality diagnostics and the identification of an indication for Percutaneous transluminal coronary angioplasty (PTCA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina Pectoris, Left Ventricular Wall Motion Abnormalities
- What is being tested?
- 2D-strain echo
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2010to Jun 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
- left ventricular wall motion abnormalities
- existent myocardial vitality MRI exploration
- reduced LV-function
- steady angina pectoris
- patients which are legally competent and which are mentally able to understand the study staff
- patients give their written consent
Who cannot join
- pregnancy or lactation
- acute or instable angina pectoris
- acute myocardial infraction in the last 3 month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hybrid Intraprocedural Imaging From 2D-Strain-echocardiography and X-ray Based Biplane Coronary Angiography for Guiding Interventional Revascularization Therapy
The investigators will check the feasibility of an intraprocedural vitality diagnostics and the identification of an indication for Percutaneous transluminal coronary angioplasty (PTCA).
Read the detailed description
After myocard vitality diagnostics with MRI patients will underwent additionally an stress echocardiography within the exploration. By this ultrasound we will measure the LV mass and the ejection fraction per apical 2-, 3- and 4-chamber view.
In addition a 2D-strain-analysis will be done to measure the systolic and diastolic strain and also the circumferential and radial strain rate parameter (by depicting three parasternal short axis views in the basal, mid-ventricular and apical plane).
These measurements will be compared with the studies-conditioned MRI-finding (as reference) to find the optimal strain-parameter and the optimal cut-off-data for an intraprocedural vitality diagnostics of the single layers (endocardial, myocardial, and epicardial) for this patient group.
The data upraised through this are compared off-line to the MRI findings.
- Being tested
- 2D-strain echo
- Keywords
- coronary stenosis, Angina pectoris, left ventricular wall motion abnormalities
- Medical subject headings
- Angina Pectoris, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2D-strain echoProcedure or surgery
2D-strain-analysis with elevation of the radial and circumferential strain and strain rate parameter(systolic and diastolic)occurs through the echocardiography.
Comparison of the echocardiography and the MRI-vitality data, calculation of a cut out of vision value of a vitality diagnosis with the help of 2D-strain-analysis.
| Study group | Role | What they receive |
|---|---|---|
| 2D-strain echo | Experimental | After myocard vitality diagnostics with MRI follows a stress echocardiography to determine the LV volumes and EF. The received Data are compare with the MRI-Data(reference)to identify the ideal strain-parameters and Cut-Off-Result for an intraprocedural vitality diagnostic of the different films (endocardial, myocardial and epicardial). Receives: Procedure: 2D-strain echo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cut-Off-Value of vital myocardial tissue
It will be determine cutt-off-value of vital myocardial tissue in comparison to MRI myocardial vitality findings.
Measured: time during hospitalization
Secondary outcomes (2)
feasibility and safety of echocardiography during catheter investigations
it will be analyzed if it is logistically possible to perform echo-test during the actual catheter investigations (feasibility) and if the patient will be exposed to any safety risk for logistic or sterility reasons.
Measured: time during hospitalization and 1 months afterwards
Determination of Strain-Parameter for identification of vital myocardial tissue
It will be determitated optimal Strain-Parameter(circumferential, systolic or diastolic)for identification of vital myocardial tissue
Measured: time during hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startApr 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Becker, MD, Principal investigator, RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389674
- Sponsor's protocol ID
- HIB-Study
- Other IDs
- CTC-A 08-001, EK 079/10
- Status last verified
- Jun 2014
- First submitted
- 3 Feb 2009
- Last updated
- 9 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Intraprocedural Imaging From 2D-Strain-echocardiography and X-ray Based Biplane Coronary Angiography for Guiding Interventional Revascularization Therapy
- ClinicalTrials.gov ID
- NCT01389674
- Acronym / sponsor ID
- HIB-Study
- Keywords
- coronary stenosis, Angina pectoris, left ventricular wall motion abnormalities
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 8 Jul 2011 (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 investigators will check the feasibility of an intraprocedural vitality diagnostics and the identification of an indication for Percutaneous transluminal coronary angioplasty (PTCA).
Detailed description
After myocard vitality diagnostics with MRI patients will underwent additionally an stress echocardiography within the exploration. By this ultrasound we will measure the LV mass and the ejection fraction per apical 2-, 3- and 4-chamber view.
In addition a 2D-strain-analysis will be done to measure the systolic and diastolic strain and also the circumferential and radial strain rate parameter (by depicting three parasternal short axis views in the basal, mid-ventricular and apical plane).
These measurements will be compared with the studies-conditioned MRI-finding (as reference) to find the optimal strain-parameter and the optimal cut-off-data for an intraprocedural vitality diagnostics of the single layers (endocardial, myocardial, and epicardial) for this patient group.
The data upraised through this are compared off-line to the MRI findings.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2D-strain echo | Experimental | Procedure: 2D-strain echoAfter myocard vitality diagnostics with MRI follows a stress echocardiography to determine the LV volumes and EF. The received Data are compare with the MRI-Data(reference)to identify the ideal strain-parameters and Cut-Off-Result for an intraprocedural vitality diagnostic of the different films (endocardial, myocardial and epicardial). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- left ventricular wall motion abnormalities
- existent myocardial vitality MRI exploration
- reduced LV-function
- steady angina pectoris
- patients which are legally competent and which are mentally able to understand the study staff
Key exclusion criteria (3 listed)
- pregnancy or lactation
- acute or instable angina pectoris
- acute myocardial infraction in the last 3 month
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 |
|---|---|---|
| 2D-strain echo2D-strain-analysis with elevation of the radial and circumferential strain and strain rate parameter(systolic and diastolic)occurs through the echocardiography. Comparison of the echocardiography and the MRI-vitality data, calculation of a cut out of vision value of a vitality diagnosis with the help of 2D-strain-analysis. | Procedure or surgery | 2D-strain echo |
Primary outcome
Cut-Off-Value of vital myocardial tissue
Time frame: time during hospitalization
It will be determine cutt-off-value of vital myocardial tissue in comparison to MRI myocardial vitality findings.
2 secondary outcomes
feasibility and safety of echocardiography during catheter investigations
Time frame: time during hospitalization and 1 months afterwards
Determination of Strain-Parameter for identification of vital myocardial tissue
Time frame: time during hospitalization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
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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.
Michael Becker, MD principal investigator
RWTH Aachen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2D-strain echo in people with Angina Pectoris and Left Ventricular Wall Motion Abnormalities, run by RWTH Aachen University at 1 site in Germany.
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 6 inclusion and 3 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: withdrawn, as of the sponsor's last update on 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was withdrawn before enrolling participants, so there are no results.
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?
Cut-Off-Value of vital myocardial tissue (time frame: time during hospitalization). 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 9 Jun 2014.