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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01440517 |
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Date of registration:
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22/09/2011 |
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Primary sponsor: |
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Public title:
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Results of Tc99m-Maraciclatide Scintigraphy in Subjects With Diabetes Mellitus and Heart Failure With Preserved Left Ventricular Ejection Fraction
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Scientific title:
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An Open-Label, Multicenter, Proof of Concept, Phase 2 Study Evaluating the Results of Tc99m-Maraciclatide Scintigraphy in Subjects With Diabetes Mellitus (DM) and Heart Failure With Preserved Left Ventricular Ejection Fraction (HFPEF) |
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Date of first enrolment:
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August 2011 |
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Target sample size:
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4 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT01440517 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Countries of recruitment
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United States
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Contacts
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Name:
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Arnold Jacobson, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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GE Healthcare |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- The subject is between 18 and 80 years of age.
- The subject was diagnosed with DM type 2 based upon accepted clinical criteria and
currently takes at least one diabetes medication.
- For HF subjects: The subject was diagnosed with HF with preserved EF within the
previous 1 year, at which time LVEF was determined to be =45%.
- For comparison subjects: The subject was determined to have diastolic dysfunction on
EKG within the previous year and currently has no signs or symptoms of HF.
- The subject has been clinically stable for at least 7 days prior to the study imaging
procedures (e.g., not experiencing continuing chest pain, hemodynamic instability,
worsening HF symptoms, or clinically significant arrhythmia).
Exclusion Criteria:
- The subject had an acute myocardial infarction within the past 30 days.
- The subject had a cardiac revascularization (e.g., percutaneous transluminal coronary
angiography [PTCA], percutaneous coronary intervention (PCI), or coronary artery
bypass graft [CABG]) within the past 30 days.
- The subject has severe renal dysfunction.
- The subject is claustrophobic or has a movement disorder that prevents him/her from
lying still in a supine position for up to 20 minutes at a time.
- The subject has participated in a research study using ionizing radiation in the
previous 12 months.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus
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Heart Failure
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Intervention(s)
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Drug: Tc99m-Maraciclatide
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Primary Outcome(s)
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Evidence of active myocardial angiogenesis/remodeling
[Time Frame: Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration.]
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Secondary Outcome(s)
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Compare 99mTc-maraciclatide uptake
[Time Frame: Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration.]
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Secondary ID(s)
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GE-078-101
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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