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Results of Tc99m-Maraciclatide Scintigraphy in Subjects With Diabetes Mellitus and Heart Failure With Preserved Left Ventricular Ejection Fraction

2. januar 2014 opdateret af: GE Healthcare

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)

The purpose of this study is to evaluate the results of 99mTc maraciclatide scintigraphy in diabetic subjects with HFPEF. A maximum of 20 subjects with Diabetes Mellitus (DM) and Heart Failure With Preserved Left Ventricular Ejection Fraction (HFPEF) will be enrolled and imaged with 99mTc maraciclatide. In addition, a maximum of 10 subjects with DM and diastolic dysfunction but no diagnosis of heart failure (HF) will be enrolled and imaged with 99mTc-maraciclatide.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

4

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • New Jersey
      • Princeton, New Jersey, Forenede Stater, 08540
        • GE Healthcare

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Tc99m-Maraciclatide
Freeze-dried powder Kit for the preparation of Maraciclatide (99mTc) Injection
Andre navne:
  • Maraciclatide (99mTc) Injection

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evidence of Active Myocardial Angiogenesis/Remodeling
Tidsramme: Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration.
Due to the lack of subject enrollment, efficacy data were not analyzed.
Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Uptake of 99mTc-maraciclatide Agent in Diabetic Subjects With Heart Failure With Preserved Left Ventricular Fraction and Subjects With Diabetes Mellitus and Asymptomatic Diastolic Dysfunction
Tidsramme: Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration.
Due to the lack of subject enrollment, efficacy data were not analyzed.
Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Studieleder: Arnold Jacobson, MD, GE Healthcare

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2011

Primær færdiggørelse (Faktiske)

1. marts 2012

Studieafslutning (Faktiske)

1. marts 2012

Datoer for studieregistrering

Først indsendt

22. september 2011

Først indsendt, der opfyldte QC-kriterier

23. september 2011

Først opslået (Skøn)

26. september 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. februar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. januar 2014

Sidst verificeret

1. januar 2014

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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