This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Shockwave Treatment for Advanced Angina in Maastricht (SWAAM)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by Maastricht University Medical Center.
Recruitment status was:  Recruiting
Medispec ltd.
Information provided by:
Maastricht University Medical Center Identifier:
First received: April 12, 2011
Last updated: July 11, 2011
Last verified: July 2011
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 Intervention
Angina Procedure: shockwave treatment

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Shockwave Treatment for Advanced Angina in Maastricht (SWAAM-study).

Resource links provided by NLM:

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Improvement of exercise tolerance [ Time Frame: after 6 months ]
    Modified Bruce protocol, changes compared to the baseline

Secondary Outcome Measures:
  • Improvement of myocardial perfusion [ Time Frame: 6 months ]
    myocardial perfusion scintigraphy changes compared to the baseline

  • Number of Patients with Adverse Events as a Measure of Safety [ Time Frame: 6 months ]
    Changes in electrocardiogram and cardiac enzymes (e.g. creatininekinase, troponin), clinical status and chestpain.

  • Improvement of quality of life [ Time Frame: 6 months ]
    Number of anginal attacks/week, use of nitrates/week

Estimated Enrollment: 60
Study Start Date: May 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: shockwave treatment
    9 treatments in 3 months

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01361659

Contact: Jindra Vainer, MD +31433875106

Maastricht University Medical Center Recruiting
Maastricht, Limburg, Netherlands, 6229HX
Contact: Jindra Vainer, MD    +31433875106   
Principal Investigator: H. Crijns, Prof Dr.         
Sponsors and Collaborators
Maastricht University Medical Center
Medispec ltd.
Principal Investigator: H. Crijns, Prof Dr. Maastricht University Medical Center
  More Information

Responsible Party: Prof Dr Harry Crijns, Maastricht University Medical Center Identifier: NCT01361659     History of Changes
Other Study ID Numbers: 07-2-008
Study First Received: April 12, 2011
Last Updated: July 11, 2011

Keywords provided by Maastricht University Medical Center:
anginal complaints
no option patients

Additional relevant MeSH terms:
Angina Pectoris
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms processed this record on September 19, 2017