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Shockwave Treatment for Advanced Angina in Maastricht (SWAAM)

Primary Purpose

Angina

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
shockwave treatment
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angina focused on measuring anginal complaints, Lithotripsy, no option patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maastricht University Medical CenterRecruiting

Outcomes

Primary Outcome Measures

Improvement of exercise tolerance
Modified Bruce protocol, changes compared to the baseline

Secondary Outcome Measures

Improvement of myocardial perfusion
myocardial perfusion scintigraphy changes compared to the baseline
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.
Improvement of quality of life
Number of anginal attacks/week, use of nitrates/week

Full Information

First Posted
April 12, 2011
Last Updated
July 11, 2011
Sponsor
Maastricht University Medical Center
Collaborators
Medispec ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01361659
Brief Title
Shockwave Treatment for Advanced Angina in Maastricht
Acronym
SWAAM
Official Title
Shockwave Treatment for Advanced Angina in Maastricht (SWAAM-study).
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2007 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Maastricht University Medical Center
Collaborators
Medispec ltd.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina
Keywords
anginal complaints, Lithotripsy, no option patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
shockwave treatment
Intervention Description
9 treatments in 3 months
Primary Outcome Measure Information:
Title
Improvement of exercise tolerance
Description
Modified Bruce protocol, changes compared to the baseline
Time Frame
after 6 months
Secondary Outcome Measure Information:
Title
Improvement of myocardial perfusion
Description
myocardial perfusion scintigraphy changes compared to the baseline
Time Frame
6 months
Title
Number of Patients with Adverse Events as a Measure of Safety
Description
Changes in electrocardiogram and cardiac enzymes (e.g. creatininekinase, troponin), clinical status and chestpain.
Time Frame
6 months
Title
Improvement of quality of life
Description
Number of anginal attacks/week, use of nitrates/week
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jindra Vainer, MD
Phone
+31433875106
Email
J.Vainer@mumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H. Crijns, Prof Dr.
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229HX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jindra Vainer, MD
Phone
+31433875106
Email
J.Vainer@mumc.nl
First Name & Middle Initial & Last Name & Degree
H. Crijns, Prof Dr.

12. IPD Sharing Statement

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Shockwave Treatment for Advanced Angina in Maastricht

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