Angina PectorisNCT01934699
Intraprocedural Determination of Myocardial Vitality Using 2 Different Imaging Methods
A study testing Cardiac ultrasound and MRI scanner 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 compare myocard vitality diagnostics using 2D-Strain echography and MRI. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Angina Pectoris, Left Ventricular Wall Motion Abnormalities
- What is being tested?
- Cardiac ultrasound and MRI scanner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2011to Jul 2016
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Typical angina pectoris symptoms
- Echocardiographic determination of regional motion disfunction of left ventricular wall
- Establishment of needly treatment of stenosis related to motion disorder based on coronar angiography.
- Feasibility of MRI-Examination.
- Patients which are legally competent and which are mentally able to understand the study staff
- Patients give their written consent
Who cannot join
- Allergy against contrast agent
- Patients with limited renal function(GFR < 60 ml/min)
- Acute or instable angina pectoris
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: Intraprocedural Determination of Myocardial Vitality Using Speckle Tracking Echocardiography Compared to Two-time MRI Diagnostics
The investigators will compare myocard vitality diagnostics using 2D-Strain echography and MRI.
Read the detailed description
Each patient with typical angina pectoris symptoms will get echocardiographic examination during the inclusion phase. If motion disorder of regional left ventricular myocardial wall is detected, patient will get coronary angiography (not study related, caused of typical angina pectoris symptoms and high probability of CHD). If coronary stenosis related to motion disorder is available, patient will be randomized in two groups during coronary angiography.
- First Group: Patient will get echocardiographic examination during coronary angiography. 2D-Strain Analysis will be performed based on data of this echocardiographic examination. Only when vitality in the contraction impaired segments will be established based on 2D-Strain Analysis, PCI (Percutaneous Coronary Intervention) will be performed.
- Second Group: Coronary angiography by patient will be canceled. Patients will get viability assessment using MRI(Magnetic resonance imaging) within the next 7 days. When vitality will be established with MRI, patient will get PCI (Percutaneous Coronary Intervention).
In addition, as part of a feasibility analysis, the possibility of a consolidation of data of coronary angiography with the ultrasound images will be researched by first group of patients. The aim is to simplify the visualization of the intraprocedural vitality detection. For this purpose, a position sensor based on electromagnetic fields (EMT) will be used during coronary angiography.
- Being tested
- Cardiac ultrasound, MRI scanner
- Keywords
- Coronary stenosis, Angina pectoris, Left ventricular wall motion abnormalities, 2D-Strain
- 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.
Cardiac ultrasoundDevice
Patient will get echocardiographic examination during coronary angiography. 2D-Strain Analysis will be performed based on data of these echocardiographic examination. Only when vitality in the contraction impaired segments will be established based on 2D-Strain Analysis, PCI will be performed.
MRI scannerDevice
Coronary angiography on patient will be canceled. Patients will get viability assessment using MRI within the next 7 days. When vitality will be established with MRI, patient will get PCI.
| Study group | Role | What they receive |
|---|---|---|
| MRI-Arm | Active comparator | Myocardial vitality determination based on MRI diagnostics. Receives: Device: MRI scanner |
| Echo-Arm | Experimental | Myocardial vitality determination using echocardiography in combination with 2D-Strain Analysis. Receives: Device: Cardiac ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
State of health score
State of health score will be determinated by all patients for the evaluation of clinical outcomes (using the standardized questionnaire on state of health (SF-36))6 months after clinical diagnostics.
Measured: 6 month after diagnistics
Secondary outcomes (3)
Left ventricular function (ejection function)
Left ventricular function (ejection function) by all patients will be determinated 6 month after diagnostics.
Measured: 6 month after diagnistics
End-diastolic and end-systolic volume.
End-diastolic and end-systolic volume will be determined by all patients 6 month after diagnostics
Measured: 6 month after diagnostics
Capture of Major Adverse Cardiac and Cerebrovascular Events(MACCE)
It will be determined, whether all patients suffered any major adverse cardiac and cerebrovascular events (MACCE) inter alia stroke, myocardial infarction, death 18 month after diagnostics
Measured: 18 month after diagnostics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startJun 2011
- Primary completionMay 2016 (estimated)
- Study completionJul 2016 (estimated)
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 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, University Hospital, Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01934699
- Sponsor's protocol ID
- 10-004
- Other IDs
- 00012377
- Status last verified
- Sep 2015
- First submitted
- 29 Aug 2013
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraprocedural Determination of Myocardial Vitality Using Speckle Tracking Echocardiography Compared to Two-time MRI Diagnostics
- ClinicalTrials.gov ID
- NCT01934699
- Acronym / sponsor ID
- 10-004
- Keywords
- Coronary stenosis, Angina pectoris, Left ventricular wall motion abnormalities, 2D-Strain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- May 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 4 Sep 2013 (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 compare myocard vitality diagnostics using 2D-Strain echography and MRI.
Detailed description
Each patient with typical angina pectoris symptoms will get echocardiographic examination during the inclusion phase. If motion disorder of regional left ventricular myocardial wall is detected, patient will get coronary angiography (not study related, caused of typical angina pectoris symptoms and high probability of CHD). If coronary stenosis related to motion disorder is available, patient will be randomized in two groups during coronary angiography.
- First Group: Patient will get echocardiographic examination during coronary angiography. 2D-Strain Analysis will be performed based on data of this echocardiographic examination. Only when vitality in the contraction impaired segments will be established based on 2D-Strain Analysis, PCI (Percutaneous Coronary Intervention) will be performed.
- Second Group: Coronary angiography by patient will be canceled. Patients will get viability assessment using MRI(Magnetic resonance imaging) within the next 7 days. When vitality will be established with MRI, patient will get PCI (Percutaneous Coronary Intervention).
In addition, as part of a feasibility analysis, the possibility of a consolidation of data of coronary angiography with the ultrasound images will be researched by first group of patients. The aim is to simplify the visualization of the intraprocedural vitality detection. For this purpose, a position sensor based on electromagnetic fields (EMT) will be used during coronary angiography.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRI-Arm | Active comparator | Device: MRI scannerMyocardial vitality determination based on MRI diagnostics. |
| Echo-Arm | Experimental | Device: Cardiac ultrasoundMyocardial vitality determination using echocardiography in combination with 2D-Strain Analysis. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Typical angina pectoris symptoms
- Echocardiographic determination of regional motion disfunction of left ventricular wall
- Establishment of needly treatment of stenosis related to motion disorder based on coronar angiography.
- Feasibility of MRI-Examination.
- Patients which are legally competent and which are mentally able to understand the study staff
Key exclusion criteria (3 listed)
- Allergy against contrast agent
- Patients with limited renal function(GFR < 60 ml/min)
- Acute or instable angina pectoris
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 |
|---|---|---|
| Cardiac ultrasoundPatient will get echocardiographic examination during coronary angiography. 2D-Strain Analysis will be performed based on data of these echocardiographic examination. Only when vitality in the contraction impaired segments will be established based on 2D-Strain Analysis, PCI will be performed. | Device | Echo-Arm |
| MRI scannerCoronary angiography on patient will be canceled. Patients will get viability assessment using MRI within the next 7 days. When vitality will be established with MRI, patient will get PCI. | Device | MRI-Arm |
Primary outcome
State of health score
Time frame: 6 month after diagnistics
State of health score will be determinated by all patients for the evaluation of clinical outcomes (using the standardized questionnaire on state of health (SF-36))6 months after clinical diagnostics.
3 secondary outcomes
Left ventricular function (ejection function)
Time frame: 6 month after diagnistics
End-diastolic and end-systolic volume.
Time frame: 6 month after diagnostics
Capture of Major Adverse Cardiac and Cerebrovascular Events(MACCE)
Time frame: 18 month after diagnostics
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
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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
University Hospital, Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac ultrasound and MRI scanner 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: status not confirmed, as of the sponsor's last update on 23 Sep 2015. 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?
Results are not available in the source record.
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?
State of health score (time frame: 6 month after diagnistics). 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 23 Sep 2015.