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Stress Induced CardiomyopathyNCT01432626

Pathogenesis of Stress-Induced Cardiomyopathy by I-123 MIBG

A study testing I-123 radiolabeled metaiodobenzylguanidine cardiac imaging in people with Stress Induced Cardiomyopathy, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stress Induced Cardiomyopathy
What is being tested?
I-123 radiolabeled metaiodobenzylguanidine cardiac imaging
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Sep 2011to Jun 2015
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: The Evaluation of the Pathogenesis of Stress-Induced Cardiomyopathy by I-123 MIBG Imaging

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.

Read the detailed description

Background: Since the initial Japanese description of Takotsubo's cardiomyopathy in 1991 as a transient systolic dysfunction of the apical or mid left ventricular segments in the absence of obstructive coronary artery disease, stress induced cardiomyopathy has been increasingly recognized in the Unites States. Takotsubo's cardiomyopathy accounts for 1.2 to 2.2 percent of all cases of acute coronary syndrome. The current American Heart Association Statistical Update estimates that approximately 1.2 million Americans will experience an acute coronary event in 2010. Based on this estimate, between 15 and 26 thousand Americans will have stress induced cardiomyopathy annually. Takotsubo's cardiomyopathy has also been described in stroke and critically ill patients. Post menopausal women are disproportionally affected, accounting for 80 to 100 percent of the patient population. These patients classically present with signs of acute heart failure or acute coronary syndrome after a severe emotional stress. The presentation may include chest pain, shortness of breath, elevated troponin enzymes, ST segment elevations, deep T-wave inversions, ventricular arrhythmias, pulmonary edema or elevated biomarkers. Cardiac catheterization reveals angiographically normal coronary arteries while the ventriculogram and the echocardiogram shows apical ballooning with basal hyperkinesis. While the majority of patients recover complete function within few days to two weeks, up to eight percent of the patients will die from the acute heart failure.

The etiology of stress-induced cardiomyopathy remains speculative. Catecholamine excess leading to microvascular dysfunction or direct cardiomyocyte toxicity is hypothesized as the most likely etiology. This hypothesis is supported by the fact that most patients with Takotsubo's cardiomyopathy experience an intense physical or emotional stress. Furthermore, several other observations support this hypothesis. First, catecholamines levels are elevated in patients with stress induced cardiomyopathy at presentation when compared to patients with acute coronary syndrome. Second, multi-vessel coronary vasospasm and transient myocardial perfusion defects have been identified repeatedly in this population. Third, myocardial biopsies show myocarditis, interstitial fibrosis and mononuclear infiltrates, signs consistent with catecholamine toxicity. Fourth, in a mouse model, elevated epinephrine levels cause a switch from beta-2 adrenoreceptor mediated Gs protein signaling to Gi protein signaling, which is negatively inotropic. These findings all support the theory that there is altered sympathetic activity in patients with stress induced cardiomyopathy.

Thus, based on the existing knowledge base of this intriguing disease, an imaging approach that specifically evaluates the sympathetic activation state of the myocardium would appear to be ideally suited to further explore pathophysiology. I-123 radiolabeled metaiodobenzylguanidine, (mIBG) imaging allows for direct analysis of cardiac sympathetic function because it is structurally similar to norepinephrine (NE), and is transported into the cardiac sympathetic neurons by human norepinephrine transporter 1 ( hNET1), in the synaptic cleft. Unlike NE, mIBG is not metabolized by monoamine oxidase or catechol-o-methyl transferase. mIBG requires an intact myocardial sympathetic nervous system for uptake, is stored in the presynaptic vesicles and is released by stimulation with acetylcholine. Experimental manipulation of cardiac sympathetic function alters mIBG uptake and distribution. Planar imaging acquisition enables evaluation of sympathetic activation, while SPECT characterizes regional abnormalities. Measurement of the heart to mediastinal ratio during early and delayed planimetry assesses the initial uptake and washout of the tracer. mIBG uptake follows one of three general patterns: good uptake and retention, good uptake with washout or poor uptake. The different patterns likely represent the level of sympathetic activation, increase in sympathetic tone and heart failure-induced damage to the myocardial sympathetic nervous system. mIBG uptake is altered in patient with diabetic neuropathy, congestive heart failure, myocardial infarction. The uptake and washout patterns correlate with severity of neuropathy, severity of congestive heart failure, congestive heart failure treatment response, improvement in ejection fraction, cardiac death and ventricular arrhythmogenic potential.

Preliminary data in patients with Takotsubo's cardiomyopathy has shown decrease in mIBG uptake with an increased washout in the acute phase, with improved retention after left ventricular functional recovery. Furthermore, regional decrease in tracer uptake corresponds to the regional wall motion abnormalities. However, a systematic exploration of mIBG uptake patterns in consecutive patients with Takotsubo's cardiomyopathy has not been performed. Of note, PET imaging with 11C Hydroxyephedrine has described similar sympathetic dysfunction in Takotsubo's cardiomyopathy.

Being tested
I-123 radiolabeled metaiodobenzylguanidine cardiac imaging
Keywords
stress induced cardiomyopathy, broken heart syndrome, Takotsubo cardiomyopathy, transient apical ballooning syndrome, apical ballooning cardiomyopathy, stress cardiomyopathy, non-ischemic cardiomyopathy
Medical subject headings
Takotsubo Cardiomyopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • I-123 radiolabeled metaiodobenzylguanidine cardiac imagingDrug

    Also called AdreVeiw

    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.

Study groups in NCT01432626
Study groupRoleWhat they receive
Stress Induced Cardiomyopathy PatientsExperimentalPatients 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.
Receives: Drug: I-123 radiolabeled metaiodobenzylguanidine cardiac imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Had an Abnormal Regional Uptake of I-123 mIBG at Baseline (Acute Phase) and the Number of Participants Who Had an Abnormal I-123 mIBG Uptake on Follow up (Recovery Phase)

    Number of participants who had an abnormal regional uptake of I-123 mIBG at baseline (acute phase) and the number of participants who had an abnormal I-123 mIBG uptake on follow up (recovery phase)

    Measured: During the acute phase (2-5 days with an expected mean 3 days) and after recovery of cardiac function (6 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionDec 2014
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01432626
Sponsor's protocol ID
PRO10080198
Status last verified
Mar 2016
First submitted
7 Sep 2011
Last updated
22 Mar 2016
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing I-123 radiolabeled metaiodobenzylguanidine cardiac imaging in people with Stress Induced Cardiomyopathy, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Had an Abnormal Regional Uptake of I-123 mIBG at Baseline (Acute Phase) and the Number of Participants Who Had an Abnormal I-123 mIBG Uptake on Follow up (Recovery Phase) (time frame: During the acute phase (2-5 days with an expected mean 3 days) and after recovery of cardiac function (6 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2016.

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