- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00584818
Dose Finding Study of PB127 Ultrasound Contrast Agent in Healthy Volunteers and Patients With Coronary Artery Disease
23. april 2008 opdateret af: Point Biomedical
A Phase 2 Dose-Finding Clinical Trial of CARDIOsphere® (PB127) in Normal Volunteers and in Patients With Known or Suspected Coronary Artery Disease
The purpose of this study is to determine the dose of PB127 for detection and/or exclusion of coronary artery disease when used with cardiac ultrasound.
This study also evaluates the safety of PB127.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
205
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
-
Long Beach, California, Forenede Stater, 90822
- Long Beach VA Medical Center Cardiology Division
-
San Diego, California, Forenede Stater, 92103
- University of California San Diego Division of Cardiology
-
-
Delaware
-
Newark, Delaware, Forenede Stater, 19713
- Alfieri Cardiology
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60637
- University of Chicago Medical Center
-
-
Kansas
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Overland Park, Kansas, Forenede Stater, 66209
- Midwest Cardiology Associates
-
Shawnee Mission, Kansas, Forenede Stater, 66204
- The Center for Cardiovascular Studies Kramer and Crouse Cardiology
-
-
Maine
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Auburn, Maine, Forenede Stater, 04210
- Androscoggin Cardiovascular Associates
-
-
Missouri
-
Kansas City, Missouri, Forenede Stater, 64111
- Cardiovascular Consultants
-
St. Louis, Missouri, Forenede Stater, 63110
- St. Louis University Medical Center
-
-
Ohio
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Cleveland, Ohio, Forenede Stater, 44195
- The Cleveland Clinic Foundation
-
-
Oregon
-
Portland, Oregon, Forenede Stater, 97239
- Oregon Health Sciences University
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- University of Pittsburgh Cardiovascular Institute
-
-
Texas
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Austin, Texas, Forenede Stater, 78705
- Austin Heart
-
Austin, Texas, Forenede Stater, 78701
- Seton Healthcare Network Brackenridge Hospital
-
-
Washington
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Spokane, Washington, Forenede Stater, 99204
- Northwest Cardiovascular Research Institute Spokane Cardiology
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Spokane, Washington, Forenede Stater, 99204
- Inland Cardiology
-
-
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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
Stages 1 and 2
- Men and women
- Ages 18 30
- Normal volunteers
- No history (or suspicion) of CAD
Stage 3
- Men and women with known or suspected CAD
- Ages 18 years and older
Scheduled for or undergone clinically indicated coronary angiography within 28 days prior to or following Study Day 1
- Coronary angiography within 28 days prior to Study Day 1 and/or SPECT must have been non-interventional
- Coronary angiography images available in digital format (non cine) for transmission to core laboratory
- Scheduled for or undergone SPECT within 28 days prior to or following Study Day 1
Exclusion Criteria:
- Unable to provide written informed consent
- Women who are pregnant or lactating
Known hypersensitivity or known contraindication to:
- Dipyridamole
- Ultrasound contrast agents (including PB127 and excipients)
- Blood, blood products, albumin, egg whites, or protein
- Use of caffeine or xanthine containing products within the 24 hours prior to PB127 administration on Study Day 1 (Stages 2 and 3)
- Previous exposure to PB127
- Inadequate echocardiographic windows
- Heart transplant
- Known right to left shunt, including atrial septal defect
- History of CABG
- Current uncontrolled ventricular tachycardia, atrial fibrillation, atrial tachycardia, or atrial flutter
- Pacemaker or defibrillator
- Unstable angina grade CCS Class IV severity with ongoing symptoms and/or ongoing infusion of IV nitroglycerin
- Second degree or greater heart block
- Hypertension (SPB >200 and/or DBP >110 mmHg on two consecutive readings within 1 hour prior to PB127 administration)
- Hypotension (SPB <90 mmHg on two consecutive readings within 1 hour prior to PB127 administration)
- Severe aortic stenosis (>100 mmHg peak transvalvar gradient or <0.6 cm2 estimated valve area)
- Pulmonary edema within the 7 days prior to Study Day 1
- Resting oxygen saturation of less than 90%
- Q wave MI or major surgery within the 7 days prior to Study Day 1
- PTCA within the 28 days prior to Study Day 1
- Chronic obstructive pulmonary disease or bronchospastic airway disease which, in the opinion of the Investigator, is significant enough to contraindicate dipyridamole
- Known history of severe pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of >50 mmHg
Liver disease, characterized by or including one or more of the following
- Elevated total bilirubin > upper limit of normal
- Currently elevated hepatic enzymes >3X upper limit of normal
- Medical conditions or other circumstances that would significantly decrease the chances of obtaining reliable data or achieving the study objectives (i.e., drug dependence, psychiatric disorder, dementia, or associated illness); extenuating circumstances or medical conditions that make it unlikely that a patient can complete the clinical trial or follow up evaluations; or other reasons for expected poor compliance with the clinical investigator's instructions
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)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
To identify the minimum effective dose of PB127
Tidsramme: 24 hours
|
24 hours
|
To identify the optimal stress infusion rate of PB127
Tidsramme: 24 hours
|
24 hours
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
To assess the efficacy of PB127 MPE using the dose and stress infusion rate identified in Stages 1 and 2
Tidsramme: 24 hours
|
24 hours
|
To evaluate the safety of PB127
Tidsramme: 24 hours
|
24 hours
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Alexander Ehlgen, MD, PhD, POINT Biomedical Corp.
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. november 2006
Primær færdiggørelse (Faktiske)
1. marts 2008
Studieafslutning (Faktiske)
1. marts 2008
Datoer for studieregistrering
Først indsendt
20. december 2007
Først indsendt, der opfyldte QC-kriterier
20. december 2007
Først opslået (Skøn)
2. januar 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
25. april 2008
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. april 2008
Sidst verificeret
1. april 2008
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 127-013
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 .
Kliniske forsøg med Koronararteriesygdom
-
IRCCS Policlinico S. DonatoRekrutteringAnomalous aorta origin of the coronary artery (AAOCA)Italien
-
University Hospital OstravaRekrutteringIn-Stent Carotis Artery RestenosisTjekkiet
-
Sohag UniversityIkke rekrutterer endnuUmblical artery Doppler under terminsgraviditetEgypten
-
Inova Health Care ServicesBoston Scientific CorporationAfsluttetKoronar angiografi | Transradial adgang | Radial arterie Intimal Medial Tykkelse | Distal Radial Artery Access (dTRA)Forenede Stater
-
Baylor College of MedicineAfsluttetLungeblødning | MAPCA - Major Aortopulmonary Collateral ArteryForenede Stater
-
Daewoong Pharmaceutical Co. LTD.UkendtMCA - Middle Cerebral Artery DissektionKorea, Republikken
-
Resicardunion nationale de formation et d'evaluation en medecine cardio-vasculaireAfsluttetHjertefejl | Akut koronarsyndrom | Koronar bypass-graft Stenose af Native Artery GraftFrankrig
-
AldagenUkendtSlag | Iskæmisk slagtilfælde | Slagtilfælde i Middle Cerebral Artery (MCA)Forenede Stater
Kliniske forsøg med PB127 for Injectable Suspension
-
Point BiomedicalAfsluttetKoronararteriesygdomForenede Stater
-
Point BiomedicalAfsluttetKoronararteriesygdomForenede Stater
-
Minia UniversityAfsluttet
-
AstraZenecaAfsluttet
-
Ferring PharmaceuticalsRekruttering
-
The Methodist Hospital Research InstituteUkendtProlaps af skedehvælving | Post-hysterektomi vaginal hvælving prolaps | Prolaps, vaginaltForenede Stater
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.RekrutteringKronisk obstruktiv lungesygdom (KOL)Kina
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Rekruttering
-
Santen Inc.AfsluttetTør øjensygdomForenede Stater
-
reMYNDRekrutteringAlzheimers sygdomHolland, Spanien