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Shockwave Treatment for Advanced Angina in Maastricht (SWAAM)

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ClinicalTrials.gov Identifier: NCT01361659
Recruitment Status : Unknown
Verified July 2011 by Maastricht University Medical Center.
Recruitment status was:  Recruiting
First Posted : May 27, 2011
Last Update Posted : July 12, 2011
Sponsor:
Collaborator:
Information provided by:

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
Angina Procedure: shockwave treatment

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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 2007
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Procedure: shockwave treatment
    9 treatments in 3 months

Outcome Measures

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


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

  2. 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.

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


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361659


Contacts
Contact: Jindra Vainer, MD +31433875106 J.Vainer@mumc.nl

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

Responsible Party: Prof Dr Harry Crijns, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01361659     History of Changes
Other Study ID Numbers: 07-2-008
First Posted: May 27, 2011    Key Record Dates
Last Update Posted: July 12, 2011
Last Verified: July 2011

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

Additional relevant MeSH terms:
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms