Shockwave Treatment for Advanced Angina in Maastricht

NCT01361659 | Unknown

• 1 other identifier: 07-2-008
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Angina

Keywords

anginal complaints; Lithotripsy; no option patients

Outcome Measures

Primary Outcomes (1)

• Improvement of exercise tolerance

  Modified Bruce protocol, changes compared to the baseline

  after 6 months

Secondary Outcomes (3)

• Improvement of myocardial perfusion

  6 months

• Number of Patients with Adverse Events as a Measure of Safety

  6 months

• Improvement of quality of life

  6 months

Interventions

shockwave treatment PROCEDURE

9 treatments in 3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Medispec ltd.: collaborator

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229HX, Netherlands

RECRUITING

MeSH Terms

Conditions

Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• H. Crijns, Prof Dr.

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jindra Vainer, MD

CONTACT

+31433875106; J.Vainer@mumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 12, 2011
• First Posted: May 27, 2011
• Study Start: May 1, 2007
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 12, 2011

Record last verified: 2011-07

Locations

NL (1)