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Pathogenesis of Stress-Induced Cardiomyopathy by I-123 MIBG

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
David M. Harris, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01432626
First received: September 7, 2011
Last updated: November 16, 2012
Last verified: November 2012
  Purpose

Objective: The objective of this pilot study is to characterize the cardiac uptake patterns of I-123 mIBG in stress-induced (Takotsubo's) cardiomyopathy.

Hypothesis: Perturbations in sympathetic innervation are the underlying pathogenesis of stress induced cardiomyopathy and will result in abnormalities in I-123 mIBG cardiac imaging. Thus, planar and SPECT I-123 MIBG imaging will provide insight into the pathogenesis of stress-induced cardiomyopathy, and may lead to the development of more specific diagnostic criteria.

Study design: This proposal is for a prospective pilot study to characterize perturbations in cardiac sympathetic innervation in patients with stress induced cardiomyopathy by performing planar and SPECT I-123 MIBG imaging during the acute presentation and after recovery of LV function.


Condition Intervention Phase
Stress Induced Cardiomyopathy
Drug: I-123 radiolabeled metaiodobenzylguanidine cardiac imaging
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Evaluation of the Pathogenesis of Stress-Induced Cardiomyopathy by I-123 MIBG Imaging

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Change from baseline Heart to Mediastinal Ratio at 6 weeks. [ Time Frame: During the acute phase (2-5 days with an expected mean 3 days) and after recovery of cardiac function (6 weeks) ] [ Designated as safety issue: No ]
    Heart to Mediastinal ratio of early and delayed I123-MIBG uptake during the acute presentation and after ejection fraction recovery H/M ratio = (mean pixel count of cardiac ROI/mean pixel count of mediastinal ROI) H/M=Heart to Mediastinal ratio, ROI= Region of interest, WR%= Global washout rate

  • Change from baseline Global Washout Rate at 6 weeks [ Time Frame: During the acute phase (2-5 days with an expected mean 3 days) and after recovery of cardiac function (6 weeks) ] [ Designated as safety issue: No ]
    Global washout rate of I123-MIBG from the acute presentation and after ejection fraction recovery WR%= [(mean cardiac pixel count(early)-mean cardiac pixel count(delayed))/(mean cardiac pixel count (early))] x 100

  • Change from baseline Ejection Fraction at 6 weeks [ Time Frame: During the acute phase (2-5 days with an expected mean 3 days) and after recovery of cardiac function (6 weeks) ] [ Designated as safety issue: No ]
    Using the Simpson's method, all left ventricular ejection fractions will be calculated during the acute phase and after functional recovery.


Estimated Enrollment: 12
Study Start Date: September 2011
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stress Induced Cardiomyopathy Patients
Patients presenting with stress induced cardiomyopathy, after meeting the Mayo criteria (normal coronary anatomy, EKG changes/Enzyme abnormalities, wall motion abnormalities consistent with stress induced cardiomyopathy and no evidence of pheochromocytoma) and signing informed consent, will receive an I123-mIBG scan to determine the sympathetic function of the heart during the acute presentation and after functional recovery.
Drug: I-123 radiolabeled metaiodobenzylguanidine cardiac imaging
All subjects will receive an intravenous injection of 10 mCi (370 MBq) of 123I-mIBG. A ±10% tolerance of the nominal dose will be allowed, thus yielding an acceptable dose range of 9 to 11 mCi (333 to 407 MBq). The investigational medicinal product will be administered in a volume of 5 mL (diluted using 0.9% sodium chloride as needed) and injected over 1 to 2 minutes. The patient will have planar and SPECT imaging performed after the dose is administered. This dosing and imaging procedure will be performed during the acute phase and after the patient has recovered cardiac function, approximately 6 weeks later. This means that each study subject will receive a total of 2 doses of I123-mIBG at 2 different time points.
Other Name: AdreVeiw

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject is ≥18 years of age at study entry.
  • The subject is able and willing to comply with study procedures and signed and dated informed consent is obtained.
  • The subject is male, or a female who is either surgically sterile (has a documented bilateral oophorectomy and/or hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom the result of a urine pregnancy test performed at screening is negative.
  • The subject's left heart catheterization (obtained as part of the clinical evaluation) is without clinically significant coronary atherosclerotic disease.
  • The subject's echocardiogram (obtained as part of the clinical evaluation) is consistent with a diagnosis of Takotsubo's Cardiomyopathy.
  • The patient's electrocardiogram or cardiac enzymes including troponin or CKMB (obtained as part of the clinical evaluation) is abnormal.
  • The patient does not have a diagnosis or suspicion of Pheochromocytoma.

Exclusion Criteria:

  • The subject has previously received I123-MIBG or I131-MIBG.
  • The subject has a ventricular pacemaker that routinely functions (>5% paced beats) or has received defibrillation (either external or via an ICD), anti-tachycardic pacing, or cardioversion to treat a previous arrhythmic event.
  • The subject was previously entered into this study or has participated in any other investigational medicinal product or medical device study within 30 days of enrollment.
  • The subject has a previous history or suspicion of significant allergic reaction or anaphylaxis to iodine or iodinated compounds.
  • The subject uses medications for non-cardiac medical conditions that are known to interfere with I123-MIBG uptake.
  • The subject had cardiac revascularization (eg, percutaneous transluminal coronary angioplasty, PCI, or CABG) or insertion of an ICD within the last 30 days.
  • The subject has a serious non-cardiac medical condition associated with significant elevation of plasma catecholamines including Pheochromocytoma.
  • The subject is claustrophobic or has a movement disorder that prevents him/her from lying still in a supine position for up to an hour at a time.
  • The subject has renal insufficiency (serum creatinine > 3.0 mg/dl [265umol/L]).
  • The subject has participated in a research study using ionizing radiation in the previous 12 months.
  • The subject has a history of Type I or Type II Diabetes Mellitus with signs of neurological involvement, signs or symptoms of neurological disease (eg, Parkinson's Disease, Multiple System Atrophy, Parkinsonian syndromes), or other diseases known to affect the sympathetic nervous system.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01432626

Contacts
Contact: Prem Soman, MD (412) 647-3435 somanp@upmc.edu
Contact: Leigh Anne Rethage, BS, BSN, RN (412) 647-7976 rethagel@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Prem Soman, MD    412-647-3435    somanp@upmc.edu   
Principal Investigator: Prem Soman, MD         
Sub-Investigator: David M Harris, MD         
Sub-Investigator: Michael Mathier, MD         
Sub-Investigator: Hunter Champion, MD, PhD.         
Sub-Investigator: William P Follansbee, M.D.         
Sub-Investigator: Saurabh Malhotra, MD, MPH         
Sub-Investigator: Anthony P Dotta, III, MD         
Sub-Investigator: Gavin W Hickey, MD         
Sponsors and Collaborators
University of Pittsburgh
GE Healthcare
Investigators
Principal Investigator: David M Harris, MD University of Pittsburgh Heart Vascular Institue
Principal Investigator: Prem Soman, MD University of Pittsburgh Heart Vascular Institute
  More Information

No publications provided

Responsible Party: David M. Harris, Co-Principle Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01432626     History of Changes
Other Study ID Numbers: PRO10080198
Study First Received: September 7, 2011
Last Updated: November 16, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Takotsubo Cardiomyopathy
Cardiomyopathies
Cardiovascular Diseases
Heart Diseases
Ventricular Dysfunction
Ventricular Dysfunction, Left
3-Iodobenzylguanidine
Antineoplastic Agents
Diagnostic Uses of Chemicals
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiopharmaceuticals
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014