Shockwave Treatment for Advanced Angina in Maastricht (SWAAM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Maastricht University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Medispec ltd.
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01361659
First received: April 12, 2011
Last updated: July 11, 2011
Last verified: July 2011
  Purpose

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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    Modified Bruce protocol, changes compared to the baseline


Secondary Outcome Measures:
  • Improvement of myocardial perfusion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    myocardial perfusion scintigraphy changes compared to the baseline

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

  • Improvement of quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Prof Dr Harry Crijns, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01361659     History of Changes
Other Study ID Numbers: 07-2-008
Study First Received: April 12, 2011
Last Updated: July 11, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

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

ClinicalTrials.gov processed this record on August 27, 2014