Efficacy of Extracorporeal Shockwave Myocardial Revascularization
NCT ID: NCT01711099
Last Updated: 2012-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
14 participants
INTERVENTIONAL
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ESMR treated
device for Extracorporeal Shockwave Myocardial Revascularization (ESMR) therapy
Interventions
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device for Extracorporeal Shockwave Myocardial Revascularization (ESMR) therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient's current and past medical condition and status be assessed using previous medical history, complete physical examination and the physicians (principle investigator's) medical opinion.
* Patient is diagnosed with chronic angina pectoris for at least 6 weeks. Diagnosis is based on medical history, complete physical examination, and core labs.
* Patients who no longer receive benefit from additional revascularization procedures (i.e. CABG or Angioplasty). Certification will be made by Heart Team.
* Patient demonstrates Exercise Tolerance Time (ETT) duration \< 10 minutes on Modified Bruce protocol.
* Patient had at least one documented myocardial segment with reversible ischemia.
* Patient is under optimum medical therapy for angina for at least 6 weeks. The optimal treatment plan is tailored to a person's age, the presence of other medical conditions, lifestyle, medication side effects, etc. Medical therapies for stable angina include ACE-inhibitors, Nitrates, Beta Blockers and Calcium Channel Blockers, trimetazidine, ivabradin. Combination of any of 3 above mentioned drugs will be considered as optimum medical therapy.
* Patient has an echocardiographic acoustic window to the target area in the myocardium utilizing one of the following views: apical 2 chamber view (2CH), apical 4 chamber view (4CH), modified parasternal long axis view (LAX) and parasternal short axis view (SAX).
Exclusion Criteria
* Patient has active endocarditis, myocarditis or pericarditis.
* Patient with moderately severe or severe valvular disease.
* Patient with known intraventricular thrombus.
* Patients who have active or non-active implantables, such as pacemakers, defibrillators, abandoned leads, or electrodes.
* Patient for who shock waves applied over any implanted device that releases substances or medications to the periphery (such as insulin pumps).
* Patient is pregnant.
* Patient with severe chronic lung disease (emphysema, pulmonary fibrosis) with difficult access to ultrasonic acoustic window.
* Patients for who shock waves applied over the area of healing fracture.
* Patients for who shock waves applied over the area of bone growth.
* Patients for who shock waves applied to the area of malignancy.
* Prior invasive malignancy, except non-melanomatous skin cancer or other malignancies with a documented disease-free survival for a minimum of 5 years.
* By the physician decision there is underlying concomitant disease or circumstance what may negatively influence the management of the patient.
18 Years
ALL
No
Sponsors
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Salus Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Béla Merkely, Prof
Role: PRINCIPAL_INVESTIGATOR
Semmelweis University Heart Center
Locations
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Kelen Hospital
Budapest, , Hungary
Semmelweis University Heart Center
Budapest, , Hungary
Countries
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Central Contacts
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Facility Contacts
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Imre Lukács, MD
Role: primary
Béla Merkely, Prof
Role: primary
Other Identifiers
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ANGEL_v01
Identifier Type: -
Identifier Source: org_study_id