Shockwave Treatment for Advanced Angina in Maastricht

Angina Clinical Trial

— SWAAM  

Official title:

Shockwave Treatment for Advanced Angina in Maastricht (SWAAM-study).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01361659
• Other study ID #: 07-2-008
• Status: Recruiting
• Phase: N/A
• First received: April 12, 2011
• Last updated: July 11, 2011
• Start date: May 2007
• Est. completion date: December 2012

Study information

• Verified date: July 2011
• Source: Maastricht University Medical Center
• Contact: Jindra Vainer, MD
• Phone: +31433875106
• Email: J.Vainer[@]mumc.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

There is an increasing number of patients with a coronary anatomy that does not allow additional revascularization procedures, while the patients suffer from angina pectoris at rest or at minimal exercise levels despite optimised medical therapy. There is a lack of therapeutic options for this group of so called "no-option patients". Goal of the project is to implement the shockwave therapy for no-option coronary artery disease patients and to evaluate its potential benefit on regional myocardial perfusion, on regional myocardial function and on the potential improvement in symptoms and quality of life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic angina pectoris CCS (Canadian Cardiological Society) III or IV with documented reversible ischemia and/or hibernation.

• Patients demonstrates exercise tolerance test (ETT) duration < 10 minutes on a modified Bruce protocol

• No possibility of traditional revascularization by coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI)

• Patient's conditions stable for at least 3 months

• Life expectancy of > 12 months.

Exclusion Criteria:

• Unstable angina pectoris

• Haemodynamically significant valvular heart disease

• Myocardial infarction <3 month prior randomization

• Evidence of intracardiac thrombus

• Contraindication for Magnetic resonance imaging (MRI) (pacemaker, metallic prostheses)

• Patient is simultaneously participating in another device or drug study, or has participated in any clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization or any Extracorporeal Shock Wave Therapy (ESWT) machine for neovascularization of a competitor company within 3 months of entry into the study.

• Patients who are unwilling or unable to cooperate with the study procedure.

• Age < 18 years

• Cardiac or pulmonary malignancy

• No informed consent

• Known depression

Study Design

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

Related Conditions & MeSH terms

• Angina
• Angina Pectoris

Intervention

Procedure:
• shockwave treatment
9 treatments in 3 months

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Medispec ltd.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of exercise tolerance	Modified Bruce protocol, changes compared to the baseline	after 6 months	No
Secondary	Improvement of myocardial perfusion	myocardial perfusion scintigraphy changes compared to the baseline	6 months	No
Secondary	Number of Patients with Adverse Events as a Measure of Safety	Changes in electrocardiogram and cardiac enzymes (e.g. creatininekinase, troponin), clinical status and chestpain.	6 months	Yes
Secondary	Improvement of quality of life	Number of anginal attacks/week, use of nitrates/week	6 months	No