SPIROCOR Coronary Outcome by Respiratory Stress Examination (SCORE)
5. november 2010 opdateret af: Spirocor
SPIROCOR Coronary Outcome by Respiratory Stress Examination - SCORE Study
The purpose of this study is to validate the accuracy of the SPIROCOR System in indicating the presence of significant coronary artery disease (S-CAD), as defined in ACC/AHA Guidelines, in subjects with suspected S-CAD.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Forventet)
1000
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35294
- University of Alabama at Birmingham
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Birmingham, Alabama, Forenede Stater, 35213
- Cardiovascular Associates
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Huntsville, Alabama, Forenede Stater, 35801
- Heart Center Research
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Arizona
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Glendale, Arizona, Forenede Stater, 85306
- Phoenix Heart, PLLC
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California
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Escondido, California, Forenede Stater, 92025
- Escondido Cardiology Associates
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Colorado
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Littleton, Colorado, Forenede Stater, 80120
- South Denver Heart Cardiology Associates
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Delaware
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Newark, Delaware, Forenede Stater, 19718
- Christiana Care Health Services
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Florida
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Clearwater, Florida, Forenede Stater, 33756
- Clearwater Cardiovascular & Interventional Consultants
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Largo, Florida, Forenede Stater, 33777
- Clearwater Cardiovascular & Interventional Consultants
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Miami, Florida, Forenede Stater, 33173
- Cardiovascular Research Center of South Florida
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Miami Beach, Florida, Forenede Stater, 33140
- Mount Sinai Medical Center
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Safety Harbor, Florida, Forenede Stater, 34695
- Clearwater Cardiovascular & Interventional Consultants
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242
- University Of Iowa Hospital, Lipid Research Clinic
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40205
- Cardiovascular Associates
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Maryland
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Columbia, Maryland, Forenede Stater, 21044
- Cardiovascular Specialists of Central Maryland, PA
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Massachusetts
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Haverhill, Massachusetts, Forenede Stater, 01830
- Pentucket Medical Associates
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55417
- Minneapolis VAMC
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New Hampshire
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Manchester, New Hampshire, Forenede Stater, 03102
- Catholic Medical Center
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New Jersey
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Cherry Hill, New Jersey, Forenede Stater, 08034
- Cardiovascular Associates of the DE Valley - Cherry Hill
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Elmer, New Jersey, Forenede Stater, 08318
- Cardiovascular Associates, DE Valley- Elmer
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Ridgewood, New Jersey, Forenede Stater, 07450
- Cardiac & Endovascular Associates
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Sewell, New Jersey, Forenede Stater, 08080
- Cardiovascular Associates, DE Valley- Sewell
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North Carolina
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Sanford, North Carolina, Forenede Stater, 27330
- Sanford Cardiology, a division of Pinehurst Medical, Inc.
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45219
- The Linder Center for Research & Education
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Elyria, Ohio, Forenede Stater, 44035
- North Ohio Research Ltd
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Youngstown, Ohio, Forenede Stater, 44501
- Humility of Mary Health Partners dba, St. Elizabeth Health Center
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Pennsylvania
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York, Pennsylvania, Forenede Stater, 17405
- Cardiac Diagnostic Associates, PC
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- MUSC
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Texas
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Tyler, Texas, Forenede Stater, 75701
- Cardiovascular Associates of East Texas
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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
30 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Subjects referred to cardology clinics for evaluation of severe coronary artery disease (S-CAD)
Beskrivelse
Inclusion Criteria:
- Subject with suspected S-CAD
- Subject able to perform the guided breathing protocol and comply with study requirements
- Subject is able and agrees to sign the informed consent form
Exclusion Criteria:
- Resting (supine) ECG evidence of ST-segment depression ≥ 1 mm in any lead or left bundle branch block or significant arrhythmia
- Current digoxin therapy
- Subject has severe valvular heart disease
- Subject has congestive heart failure NYHA class III/IV
- Subject has known history of myocardial infarction (ST elevation or non ST elevation)
- Subject had previous coronary revascularization: CABG or PCI
- Subject has pacemaker or ICD that controls sinus
- Morbidly obese subject (BMI ≥ 40)
- Subject has any significant medical condition which, at the investigator's discretion, may interfere with the subject's optimal participation in the study; and
- Subject is currently participating in another investigational product clinical study that the investigator believes may interfere with the outcome of this study
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
RSR vs. S-ECG in subjects suspected with S-CAD
Tidsramme: 3 weeks window
|
3 weeks window
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Ron Waksman, MD, MedStar Health Research Institute
- Ledende efterforsker: William Weintraub, MD, Christiana Care Health Systems
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. februar 2010
Datoer for studieregistrering
Først indsendt
20. januar 2010
Først indsendt, der opfyldte QC-kriterier
20. januar 2010
Først opslået (Skøn)
22. januar 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
7. november 2010
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. november 2010
Sidst verificeret
1. november 2010
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CM-102-005
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 .