Refractory Angina PectorisANGELNCT01711099
Efficacy of Extracorporeal Shockwave Myocardial Revascularization
A study testing device for Extracorporeal Shockwave Myocardial Revascularization (ESMR) therapy in people with Refractory Angina Pectoris, run by Salus Ltd. at 2 sites in Hungary.
Trial summary
Clinical research to justify effectiveness of the Extracorporeal Shockwave Myocardial Revascularization (ESMR) Therapy for treatment of patients with reversible myocardial ischemia secondary to Coronary Artery Disease (CAD) and therapy resistant stable angina pectoris. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Angina Pectoris
- What is being tested?
- device for Extracorporeal Shockwave Myocardial Revascularization (ESMR) therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesHungary
- Study dates
- Oct 2012to Sep 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
- Patient with a signed Informed Consent Form.
- 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).
Who cannot join
- Patient who will substantially benefit from additional revascularization procedures such as additional CABG or angioplasty therapies. This determination will be made and certified by the Heart Team.
- 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).
Show all 13Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Hungary2 sites, 2 recruiting
- Recruiting
Kelen Hospital
Budapest
Imre Lukács, MD, +36 20 914 7300, luxi6@freemail.hu
Imre Lukács, MD
- Recruiting
Semmelweis University Heart Center
Budapest
Béla Merkely, Prof, +36 1 4586840, titkarsag@kardio.sote.hu
Zoltán Jambrik, MD
About this study
Official title: Hungarian Study on the Efficacy of Extracorporeal Shockwave Myocardial Revascularization in Patients With Therapy-refracter Angina Pectoris
Clinical research to justify effectiveness of the Extracorporeal Shockwave Myocardial Revascularization (ESMR) Therapy for treatment of patients with reversible myocardial ischemia secondary to Coronary Artery Disease (CAD) and therapy resistant stable angina pectoris.
- Conditions
- Refractory Angina Pectoris
- Being tested
- device for Extracorporeal Shockwave Myocardial Revascularization (ESMR) therapy
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
device for Extracorporeal Shockwave Myocardial Revascularization (ESMR) therapyDevice
Also called Cardiospec system
| Study group | Role | What they receive |
|---|---|---|
| ESMR treated | Experimental | Not described Receives: Device: device for Extracorporeal Shockwave Myocardial Revascularization (ESMR) therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in myocardial ischaemia profile during dobutamine induced stress echocardiography
Measured: baseline and 6 months
Secondary outcomes (5)
Improvement in the angina pectoris CCS Stage
Measured: baseline and 3, 6 months
Improvement in angina status using Seattle Angina Questionnaire
Measured: baseline and 3, 6 months
The change in walking time using the modified Bruce exercise test
Measured: baseline and 3, 6 months
The change in basal transthoracal echocardiographic parameters
Measured: baseline and 3, 6 months
The decrease in nitrate use during the unchanged everyday activity reported by the patients in the "Nitrate Usage Log"
Measured: baseline and 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salus Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Béla Merkely, Prof, Principal investigator, Semmelweis University Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711099
- Sponsor's protocol ID
- ANGEL_v01
- Acronym
- ANGEL
- Status last verified
- Oct 2012
- First submitted
- 16 Oct 2012
- Last updated
- 25 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hungarian Study on the Efficacy of Extracorporeal Shockwave Myocardial Revascularization in Patients With Therapy-refracter Angina Pectoris
- ClinicalTrials.gov ID
- NCT01711099
- Acronym / sponsor ID
- ANGEL / ANGEL_v01
- Conditions
- Refractory Angina Pectoris
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Salus Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Sep 2013 (estimated)
- First posted
- 22 Oct 2012 (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.
Clinical research to justify effectiveness of the Extracorporeal Shockwave Myocardial Revascularization (ESMR) Therapy for treatment of patients with reversible myocardial ischemia secondary to Coronary Artery Disease (CAD) and therapy resistant stable angina pectoris.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESMR treated | Experimental | Device: device for Extracorporeal Shockwave Myocardial Revascularization (ESMR) therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient with a signed Informed Consent Form.
- 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.
Key exclusion criteria (13 listed)
- Patient who will substantially benefit from additional revascularization procedures such as additional CABG or angioplasty therapies. This determination will be made and certified by the Heart Team.
- 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.
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 |
|---|---|---|
| device for Extracorporeal Shockwave Myocardial Revascularization (ESMR) therapyAlso: Cardiospec system | Device | ESMR treated |
Primary outcome
Improvement in myocardial ischaemia profile during dobutamine induced stress echocardiography
Time frame: baseline and 6 months
5 secondary outcomes
Improvement in the angina pectoris CCS Stage
Time frame: baseline and 3, 6 months
Improvement in angina status using Seattle Angina Questionnaire
Time frame: baseline and 3, 6 months
The change in walking time using the modified Bruce exercise test
Time frame: baseline and 3, 6 months
The change in basal transthoracal echocardiographic parameters
Time frame: baseline and 3, 6 months
The decrease in nitrate use during the unchanged everyday activity reported by the patients in the "Nitrate Usage Log"
Time frame: baseline and 3, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2012.
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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.
Béla Merkely, Prof principal investigator
Semmelweis University Heart Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing device for Extracorporeal Shockwave Myocardial Revascularization (ESMR) therapy in people with Refractory Angina Pectoris, run by Salus Ltd. at 2 sites in Hungary.
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 8 inclusion and 13 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 25 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary. 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?
Contact Béla Merkely, Prof. (+36 1 4586840, titkarsag@kardio.sote.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in myocardial ischaemia profile during dobutamine induced stress echocardiography (time frame: baseline and 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 25 Oct 2012.