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ST Segment Detection Study (ST Detect)

30. januar 2019 opdateret af: Medtronic Cardiac Rhythm and Heart Failure
The purpose of ST Detect study is to evaluate whether naturally occurring spontaneous coronary events and exercise induced cardiac ischemia, give rise to detectable changes on intracardiac electrogram (EGM) signals in patients that are indicated for an Implantable Cardioverter Defibrillator (ICD) who have coronary artery disease.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

175

Kontakter og lokationer

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

Studiesteder

  • Belgien
      • Liege, Belgien
  • Danmark
      • Copenhagen, Danmark
  • Forenede Stater
    • Alaska
      • Anchorage, Alaska, Forenede Stater, 99508
    • Florida
      • Brandon, Florida, Forenede Stater, 33511
      • Orlando, Florida, Forenede Stater, 32806
    • Iowa
      • Davenport, Iowa, Forenede Stater, 52803
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55407
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64111
    • New York
      • Mineola, New York, Forenede Stater, 11501
      • Stony Brook, New York, Forenede Stater, 11794
    • North Carolina
      • Gastonia, North Carolina, Forenede Stater, 28054
      • Raleigh, North Carolina, Forenede Stater, 27610
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45219
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37203
    • Texas
      • Austin, Texas, Forenede Stater, 78705
    • Vermont
      • Burlington, Vermont, Forenede Stater, 05401
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23225
    • West Virginia
      • Morgantown, West Virginia, Forenede Stater, 26505
  • Holland
      • Zwolle, Holland
  • Norge
      • Kristiansand, Norge
  • Tyskland
      • Berlin, Tyskland
      • Heidelberg, Tyskland
      • Nuremberg, Tyskland
  • Østrig
      • Linz, Østrig

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

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Subjects coming into the hospital or the emergency room needing a defibrillator device having had coronary artery disease as outlined in the inclusion criteria.

Beskrivelse

Inclusion Criteria:

  • Subject is indicated for an ICD implantation

  • AND subject must meet ONE of the following:

    • Prior acute coronary event
    • Previously underwent Percutaneous Coronary Intervention (PCI) or stent procedure
    • Multivessel disease
    • Positive stress test completed with evidence of ischemic heart disease, as determined by physician, and no subsequent successful revascularization

Exclusion Criteria:

  • Subject is currently dependent on ventricular pacing
  • Subject has Left Bundle Brunch Block (LBBB) and/or wide QRS
  • Subject has chronic Atrial Fibrillation (AF)
  • Subject has dementia
  • Subject is indicated for a single chamber device
  • Subject requires a right sided or abdominal ICD implant
  • Subject is pregnant or in fertile age without secure birth control
  • Subject has New York Heart Association (NYHA) class IV or refractory heart failure
  • Subject is not expected to survive greater than 12 months
  • Subject is participating in other confounding research studies

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
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With ST Segment Changes During Myocardial Infarction
Tidsramme: Implant to 2 years
The primary objective of the study was to observe if there are any detectable ST segment changes on an electrogram (EGM) signal from an implanted cardiac defibrillator (ICD) during myocardial infarctions among study participants.
Implant to 2 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Occurrence of Spontaneous Coronary Event
Tidsramme: Implant to 2 years
During the study, spontaneous coronary ischemic events were categorized as STEMI, Non-ST elevated myocardial infarction (NSTEMI), or Unstable Angina. This objective was to provide estimates of rates per patient year for the study population. Rates are presented as: Average number of events per patient year (95% Confidence Interval)
Implant to 2 years
ST Segment Changes Measured by an ICD in Subjects Who Test Positive for Ischemia During an Exercise Stress Test
Tidsramme: One-month follow-up visit
Patients underwent an exercise stress test at their one month study visit. This objective was to summarize the magnitude of the hearts electrical activity signal measured by the implanted ICD during a positive exercise stress test for ischemia.
One-month follow-up visit
Number of Years of Stored Data in a Database of the Hearts Electrical Activity in This Specific Patient Population to be Used for Future Research.
Tidsramme: Implant to 2 years
The device in this study included an additional capacity to collect and store information about the hearts electrical activity specific to ischemic heart disease. This additional capacity of the device is not currently available in market release ICDs. There is no measure to this objective, other than reporting the number of follow-up years of data accrued, which can be used by Medtronic for additional research.
Implant to 2 years
Participants That Consented to Wear a Holter Monitor for a Period of 24 Hours to Collect Heart Sounds Data.
Tidsramme: Six-month follow-up visit
When study subjects completed their six-month follow-up visit, they were asked if they would consent to wear a Holter monitor for a period of 24 hours to collect Heart Sounds data. The study subject would have to return to the center the following day to return the Holter monitor and have their ICD EGM vectors reprogrammed.
Six-month follow-up visit

Samarbejdspartnere og efterforskere

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

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Efterforskere

  • Ledende efterforsker: George Crossley, MD, St. Thomas Research Institute and University of Tennessee College of Medicine Nashville, TN
  • Ledende efterforsker: Timothy Henry, MD, Minneapolis Heart Institute Foundation Minneapolis, MN

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. april 2008

Primær færdiggørelse (Faktiske)

1. november 2010

Studieafslutning (Faktiske)

1. marts 2011

Datoer for studieregistrering

Først indsendt

29. juni 2009

Først indsendt, der opfyldte QC-kriterier

30. juni 2009

Først opslået (Skøn)

2. juli 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. februar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. januar 2019

Sidst verificeret

1. januar 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ST Detect

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

Kliniske forsøg med ICD

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Sponsorer og samarbejdspartnere

Medicinske tilstande

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner