Improvement of ischemia and myocardial blood flow in patients with ischemic cardiomyopathy after treatment with Electric Shock Wave Therapy using CMR

Recruiting

Conditions: Heart failure
ischemic cardiomyopathy
10019280
10003216

Registration Number: NL-OMON33662

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 8

Inclusion Criteria

* Patient is male or female 18 years or older.
* Patient is diagnosed with ischemic cardiomyopathy. I.e. a significantly impaired left ventriculair dysfunction (left ventricular ejection fraction * 35 to 40 percent) that results from coronary artery disease based on a coronary angiogram.
* Patient has documented myocardial segments with reversible ischemia and or hibernation.
* Patient is classified as NYHA class II-IV.
* Patient should be on a stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
* Patients where angioplasty and bypass are not indicated because of anatomical or procedural reasons or frequent reocclusion / restenosis following traditional revascularization.
* Patient has refused to undergo another angioplasty or CABG.

Exclusion Criteria

* Patient has chronic lung disease including emphysema and pulmonary fibrosis.
* Patient has active endocarditis, myocarditis or pericarditis.
* 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.
* Patients who are unwilling or unable to cooperate with study procedure.
* Patients with renal dysfunction with eGFR<30 ml/min
* Patients who are unwilling to quit smoking during the study procedure (including screening phase)
* Patients who had MI less than 3 months prior to treatment
* Patients who are diagnosed with a 3rd and 4th degree heart valve disease.
* Patient with intraventricular thrombus
* Patient is pregnant
* Patient with a malignancy in the area of treatment

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Improvement in myocardial blood flow and occurrence of reverse remodeling after<br /><br>treatment of patients with Ni-Cath based on MRI. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints consist of wall motion abnormalities, left ventricular<br /><br>function, and improvement in NYHA class based on MRI and Quality Of Life score.</p><br>