Ischemic Cardiomyopathy Clinical Trial
— RHIMES-HFNCT number | NCT02573207 |
Other study ID # | Pending |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | April 9, 2019 |
Verified date | April 2021 |
Source | Intermountain Health Care, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study will collect clinical, echocardiographic, nuclear imaging and hemodynamic data in a group of patients with end stage ischemic cardiomyopathy undergoing left ventricular assist device (LVAD) implantation to investigate the incidence of recovery of myocardial function when supported with LVADs, and to study the association between hibernating myocardium and myocardial recovery in this population.
Status | Terminated |
Enrollment | 2 |
Est. completion date | April 9, 2019 |
Est. primary completion date | April 9, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Male or non-pregnant female >= 18 years of age. 2. End stage chronic and dilated ischemic cardiomyopathy requiring LVAD support. 3. Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures. Ischemic cardiomyopathy is defined by a LVEF < 40% and any of the following: - History of myocardial infarction or revascularization. - History of angina or chest pain and evidence of scarring in non-invasive imaging studies corresponding to previous myocardial infarction. - Presence of = 75% stenosis of the left main or proximal left anterior descending artery, or = 75% stenosis of 2 or more epicardial vessels in a patient with unexplained cardiomyopathy. Exclusion Criteria: - Pregnant and/or lactating women and women of child bearing potential who are not using acceptable means of contraception. Women of childbearing potential must be using adequate measures of contraception (as determined by the Investigator) to avoid pregnancy and should be highly unlikely to conceive during the study period. Women of childbearing potential must have a negative pregnancy test at screen. - Patients with acute forms of HF: acute onset of symptoms < 3 months, no left and right ventricular dilation. - Other conditions that in the opinion of the Principal Investigator may increase risk to the subject and/or compromise the quality of the clinical trial. |
Country | Name | City | State |
---|---|---|---|
United States | Intermountain Heart Institute | Murray | Utah |
Lead Sponsor | Collaborator |
---|---|
Intermountain Health Care, Inc. | Intermountain Research and Medical Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recovery of Myocardial Function | Recovery of myocardial function assessed continuously, using echocardiographic variables (LVEF, circumferential strain and strain rate, segmental strain and strain rate). | 2 weeks prior to LVAD implant and 1, 2, 3, 4, 6, 9 and 12 months post LVAD implant | |
Secondary | Change in the Proportion of Viable, Hibernating Myocardium and Scar after LVAD Implant | Change in the proportion of viable, hibernating myocardium and scar after LVAD implant, measured using Th-201 Rest-Redistribution Viability Study. | 2 weeks prior to LVAD implant and 2 months post LVAD implant |
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