- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00487903
Evaluation and Optimization of PB127 Myocardial Perfusion Echocardiography on Ultrasound Systems
1. juli 2008 opdateret af: Point Biomedical
A Phase 2 Trial of PB127 Myocardial Perfusion Echocardiography to Evaluate and Optimize Additional Ultrasound Imaging Systems
The purpose of this clinical trial is to evaluate various commercially available ultrasound systems and to identify imaging parameters to be used with these systems (along with the contrast agent PB127) as well as to further evaluate the safety of PB127.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
40
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Kansas
-
Overland Park, Kansas, Forenede Stater, 66209
- Midwest Cardiology Associates
-
-
North Carolina
-
Durham, North Carolina, Forenede Stater, 27710
- Duke University Medical Center
-
-
Texas
-
Dallas, Texas, Forenede Stater, 75226
- Baylor Research Institute
-
-
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:
1. Men and women
- Normal volunteers (18 30 years old), with no history of CAD
- Patients (≥ 18 years old) with known or suspected CAD, scheduled for or undergone clinically indicated coronary angiography 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
- 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 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 |
|---|---|
|
Determination of optimal machine settings and imaging parameters for myocardial perfusion for a variety of ultrasound imaging systems to be used in upcoming clinical trials
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. september 2007
Primær færdiggørelse (Faktiske)
1. marts 2008
Studieafslutning (Faktiske)
1. marts 2008
Datoer for studieregistrering
Først indsendt
15. juni 2007
Først indsendt, der opfyldte QC-kriterier
18. juni 2007
Først opslået (Skøn)
19. juni 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
3. juli 2008
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juli 2008
Sidst verificeret
1. juli 2008
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 127-015
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 .