Efficacy of Extracorporeal Shockwave Myocardial Revascularization

Refractory Angina Pectoris Clinical Trial

— ANGEL  

Official title:

Hungarian Study on the Efficacy of Extracorporeal Shockwave Myocardial Revascularization in Patients With Therapy-refracter Angina Pectoris

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01711099
• Other study ID #: ANGEL_v01
• Status: Recruiting
• Phase: N/A
• First received: October 16, 2012
• Last updated: October 24, 2012
• Start date: October 2012

Study information

• Verified date: October 2012
• Source: Salus Ltd.
• Contact: Béla Merkely, Prof.
• Phone: +36 1 4586840
• Email: titkarsag[@]kardio.sote.hu
• Is FDA regulated: No
• Health authority: Hungary: Institutional Ethics Committee
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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).

• 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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Refractory Angina Pectoris

Intervention

Device:
• device for Extracorporeal Shockwave Myocardial Revascularization (ESMR) therapy

Locations

Country	Name	City	State
Hungary	Kelen Hospital	Budapest
Hungary	Semmelweis University Heart Center	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Salus Ltd.

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in myocardial ischaemia profile during dobutamine induced stress echocardiography		baseline and 6 months	No
Secondary	Improvement in the angina pectoris CCS Stage		baseline and 3, 6 months	No
Secondary	Improvement in angina status using Seattle Angina Questionnaire		baseline and 3, 6 months	No
Secondary	The change in walking time using the modified Bruce exercise test		baseline and 3, 6 months	No
Secondary	The change in basal transthoracal echocardiographic parameters		baseline and 3, 6 months	No
Secondary	The decrease in nitrate use during the unchanged everyday activity reported by the patients in the "Nitrate Usage Log"		baseline and 3, 6 months	No