AnginaAmsterdamNCT01287910
Transmyocardial Laser Revascularization and Cardiovascular Magnetic Resonance Imaging
A study testing Cardiac MRI in people with Angina and Chest Pain, run by Piedmont Healthcare at 1 site in United States.
Trial summary
The primary goal of this study is to better understand how Transmyocardial Laser Revascularization (TMR) affects the functioning of the heart and, in turn, relieves angina in individuals with coronary heart disease using Magnetic Resonance (MR) images and Computed Tomography (CT) images in some patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina, Chest Pain
- What is being tested?
- Cardiac MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Aug 2013
- 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
- Male or female 18 years of age or over
- Patients with medically refractory, severe, class III or IV angina based on the Canadian Cardiovascular Society angina scale as determined by a physician
- Ejection fraction 25% or greater
- Patients with significant ischemia in the myocardium and who are NOT candidates for treatment by direct coronary revascularization methods (i.e., CABG or PCI)
- Ability and willingness to consent and Authorization for use of PHI
Who cannot join
- Patient cannot undergo a surgical procedure or general anesthesia
- Patient not eligible for CMR study
- Severe unstable angina
- Q-wave MI within 3 weeks prior to TMR
- NQWMI within 2 weeks prior to TMR
- Decompensated heart failure (class III/IV) at the time of procedure
Show all 11Show fewer
- Known increased bleeding risk
- Implanted pacemaker or defibrillator
- Clinically unstable arrhythmia
- Not able or willing to adhere to the study tests and procedures
- Inability or unwillingness to consent and Authorization for use of PHI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Transmyocardial Laser Revascularization on Myocardial Perfusion and Left Ventricular Structure by Cardiovascular Magnetic Resonance Imaging and Dynamic Volumetric Computed Tomography
The primary goal of this study is to better understand how Transmyocardial Laser Revascularization (TMR) affects the functioning of the heart and, in turn, relieves angina in individuals with coronary heart disease using Magnetic Resonance (MR) images and Computed Tomography (CT) images in some patients.
- Conditions
- Angina, Chest Pain
- Being tested
- Cardiac MRI
- Keywords
- Cardiac, Angina, Chest pain
- Medical subject headings
- Angina Pectoris, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRIOther
Cardiac MRI within 30 days prior to TMR procedure and 6 months after TMR procedure.
| Study group | Role | What they receive |
|---|---|---|
| All Patients | Other | All patients undergo the same study procedures Receives: Other: Cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of coronary arteries with blood flow defects evaluated by magnetic resonance imaging (MRI) or computed tomography (CT)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2013
- Study completionAug 2013
Why it stopped: Lack of patient population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnginaStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piedmont Healthcare
- Sponsor type
- University, hospital or other
- Collaborators
- Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
- Responsible party
- Sponsor
- Investigators
- Morris Brown, MD, Principal investigator, Piedmont Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287910
- Sponsor's protocol ID
- Amsterdam
- Acronym
- Amsterdam
- Status last verified
- Aug 2013
- First submitted
- 31 Jan 2011
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transmyocardial Laser Revascularization on Myocardial Perfusion and Left Ventricular Structure by Cardiovascular Magnetic Resonance Imaging and Dynamic Volumetric Computed Tomography
- ClinicalTrials.gov ID
- NCT01287910
- Acronym / sponsor ID
- Amsterdam / Amsterdam
- Conditions
- Angina, Chest Pain
- Keywords
- Cardiac, Angina, Chest pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of patient population
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Piedmont HealthcareUniversity, hospital or other
- Collaborators
- Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
- Study start
- Jan 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 2 Feb 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 primary goal of this study is to better understand how Transmyocardial Laser Revascularization (TMR) affects the functioning of the heart and, in turn, relieves angina in individuals with coronary heart disease using Magnetic Resonance (MR) images and Computed Tomography (CT) images in some patients.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Patients | Other | Other: Cardiac MRIAll patients undergo the same study procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female 18 years of age or over
- Patients with medically refractory, severe, class III or IV angina based on the Canadian Cardiovascular Society angina scale as determined by a physician
- Ejection fraction 25% or greater
- Patients with significant ischemia in the myocardium and who are NOT candidates for treatment by direct coronary revascularization methods (i.e., CABG or PCI)
- Ability and willingness to consent and Authorization for use of PHI
Key exclusion criteria (11 listed)
- Patient cannot undergo a surgical procedure or general anesthesia
- Patient not eligible for CMR study
- Severe unstable angina
- Q-wave MI within 3 weeks prior to TMR
- NQWMI within 2 weeks prior to TMR
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 MRICardiac MRI within 30 days prior to TMR procedure and 6 months after TMR procedure. | Other | All Patients |
Primary outcome
Number of coronary arteries with blood flow defects evaluated by magnetic resonance imaging (MRI) or computed tomography (CT)
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Lack of patient population). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2013.
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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.
Morris Brown, MD principal investigator
Piedmont Heart Institute
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 MRI in people with Angina and Chest Pain, run by Piedmont Healthcare at 1 site in United States.
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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 5 Sep 2013. 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 United States. 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 stopped early (reason given: Lack of patient population). 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?
Number of coronary arteries with blood flow defects evaluated by magnetic resonance imaging (MRI) or computed tomography (CT) (time frame: 6 months). 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 5 Sep 2013.