Shockwave Treatment for Advanced Angina in Maastricht (SWAAM)

Shockwave Treatment for Advanced Angina in Maastricht (SWAAM-study).

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.

Study Overview

• Status: Unknown
• Conditions: Angina
• Intervention / Treatment: Procedure: shockwave treatment

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229HX
      • Recruiting
      • Maastricht University Medical Center
      • Contact: Jindra Vainer, MD; Phone Number: +31433875106; Email: J.Vainer@mumc.nl
      • Principal Investigator: H. Crijns, Prof Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of exercise tolerance	Modified Bruce protocol, changes compared to the baseline	after 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of myocardial perfusion	myocardial perfusion scintigraphy changes compared to the baseline	6 months
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.	6 months
Improvement of quality of life	Number of anginal attacks/week, use of nitrates/week	6 months

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Medispec ltd.
• Investigators: Principal Investigator: H. Crijns, Prof Dr., Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Anticipated): July 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: April 12, 2011
• First Submitted That Met QC Criteria: May 26, 2011
• First Posted (Estimate): May 27, 2011

Study Record Updates

• Last Update Posted (Estimate): July 12, 2011
• Last Update Submitted That Met QC Criteria: July 11, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Lithotripsy; anginal complaints; no option patients
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris
• Other Study ID Numbers: 07-2-008