SWAAM: Shockwave Treatment for Advanced Angina in Maastricht

• Sponsor: Maastricht University Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01361659
• Collaborator: Medispec ltd. (Other)
• Enrollment: 60
• Location: 1
• Duration (Months): 67.1
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Angina	Procedure: shockwave treatment	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Shockwave Treatment for Advanced Angina in Maastricht (SWAAM-study).
• Study Start Date: May 1, 2007
• Anticipated Primary Completion Date: Jul 1, 2012
• Anticipated Study Completion Date: Dec 1, 2012

Outcome Measures

Primary Outcome Measures

1. Improvement of exercise tolerance [after 6 months]

   Modified Bruce protocol, changes compared to the baseline

Secondary Outcome Measures

1. Improvement of myocardial perfusion [6 months]

   myocardial perfusion scintigraphy changes compared to the baseline

2. Number of Patients with Adverse Events as a Measure of Safety [6 months]

   Changes in electrocardiogram and cardiac enzymes (e.g. creatininekinase, troponin), clinical status and chestpain.

3. Improvement of quality of life [6 months]

   Number of anginal attacks/week, use of nitrates/week

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maastricht University Medical Center	Maastricht	Limburg	Netherlands	6229HX

Sponsors and Collaborators

• Maastricht University Medical Center
• Medispec ltd.

Investigators

• Principal Investigator: H. Crijns, Prof Dr., Maastricht University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01361659
• Other Study ID Numbers: 07-2-008
• First Posted: May 27, 2011
• Last Update Posted: Jul 12, 2011
• Last Verified: Jul 1, 2011

• Keywords provided by , ,: anginal complaints; Lithotripsy; no option patients
• Additional relevant MeSH terms: Angina Pectoris

Study Results

No Results Posted as of Jul 12, 2011