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Pilot Safety Study of Coronary CTA for the Diagnosis of Acute Coronary Syndrome in the Emergency Room

15. oktober 2013 opdateret af: José Ortiz

Usefulness of Coronary CTA for the Diagnosis of Acute Coronary Syndrome in the Emergency Room.

The Diagnosis of acute coronary syndrome in patients presenting with acute chest pain is problematic when both, electrocardiogram and serum troponins are normal. Multidetector row computed tomography angiography (CTA) allows direct and rapid non-invasive visualization of coronary artery disease.

The investigator's aim is to assess the diagnostic accuracy and safety of a novel diagnostic strategy based on MDCT as compared to a strategy using stress echocardiography in the workup of patient with chest pain, normal electrocardiogram, normal troponins and suspected coronary artery disease. Additionally, the cost associated with both strategies will be compared.

Methods. A total of 150 patients with acute chest pain coming to the emergency room with intermediate probability of significant coronary artery disease, normal ECG and troponins will be prospectively randomized to MDCT or stress echocardiography with exercise. Patients showing coronary stenosis >50% at MDCT or abnormal stress echocardiography or inconclusive results will be admitted for further study. The primary endpoint of the study is the detection of an acute coronary syndrome, defined as typical or atypical angina with documented significant coronary artery disease (>50% stenosis) on invasive coronariography, a positive stress test or the occurrence of cardiac death, myocardial infarction or need for revascularization during 6 month follow-up. All MDCT angiograms and echocardiograms will be evaluated by an experienced radiologist and cardiologist.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Design and Aim: This is a prospective pilot study to evaluate the role of multidetector row computed tomography angiography (CTA) to rule out Acute Coronary Syndrome among patients presenting to the ER with chest pain complaints, non-diagnostic ECG and normal troponins and intermediate pre-test probability for significant CAD.

Methods: Following the initial clinical evaluation and the results of initial ECG, blood test and X-ray, patients meeting the inclusion criteria will be randomized to undergo either a CTA scan or a Exercise Stress Echocardiogram to rule out significant coronary artery disease.

CTA will be carried out in a 64 or 128 slice-CT Scanner (SIEMENS,Somaton Sensation 64 or 128-Flash Definition)following iv administration of iodinated contrast (bolus: 5cc x acquisition time (seg)+ 10 cc). Images will be interpreted by two experienced physicians (radiologist and cardiologist)

Stress Echocardiography will be performed and interpreted by an experienced Echocardiographer (cardiologist).

Clinical decision making: Patients with a positive or inconclusive test in each arm will be admitted to the hospital for treatment or further additional testing, while patients with negative results will be discharged from the ER.

Safety issues: A phone call and chart review will be performed one month and 6 months follow-up to register the occurrence of any major adverse cardiac events, as well as new consultation for chest pain.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

150

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Spanien
    • Catalonia
      • Barcelona, Catalonia, Spanien, 08036
        • Hospital Clinic Barcelona

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

35 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patient is in Sinus Rhythm
  • Typical or atypical chest pain lasting more than 5 min in the last 24 hs.
  • Estimated pre-test probability of significant coronary artery disease more than 15%.
  • Absence of ECG changes suggestive of myocardial ischemia (ST-segment deviation >1 mm or T Wave inversion > 4 mm in at least two contiguous leads).
  • Negative initial troponins I at admission (<0.05 ng/ml)

Exclusion Criteria:

  • Known allergy to iodinated contrast.
  • Known renal insufficiency or Creatinine >1.5 mg/dl at admission.
  • History of known coronary artery disease or prior myocardial revascularization
  • Any of the following:hemodynamic instability, persistent chest pain despite treatment, Systolic blood pressure <100 mm Hg.
  • Cardiac arrhythmia with rapid or irregular ventricular response.
  • Inability to perform an exercise test.
  • Patient is incapable of providing informed consent.

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Computed coronary angiography (CTA)
Patients will undergo a MDCT as the initial diagnostic test to rule out Acute Coronary Syndrome
Stråling: computed coronary angiography
Patients will be pre-medicated with atenolol 50 mg 1h prior to the scan.
Andre navne:
  • coronary cta
  • SIEMENS 64/128 slice CT scanner
Aktiv komparator: Exercise stress echocardiography
Patients will undergo exercise stress echocardiography as the initial diagnostic test to rule out acute coronary syndrome.
Procedure: Exercise stress echocardiography
Limited by symptoms
Andre navne:
  • Treadmil exercise stress echocardiography

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diagnosis of Acute Coronary Syndrome during admission or occurrence of Major Acute Cardiac Events after discharge
Tidsramme: 6 months
Major adverse cardiac events include: All cause mortality, acute myocardial infarction, need for coronary revascularization
6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Major adverse cardiac events on follow-up
Tidsramme: 6 months
Safety endpoint: occurrence of MACE among discharged patients in whom acute coronary syndrome has been ruled out according to the test results
6 months
Costs during admission (Euros)
Tidsramme: 6 months
The total costs derivated from the admission between the two arms of the study will be compared. Results will be reported in Euros, and will include the costs of the CTA or Stress echocardiography as well as additional tests performed during admission.
6 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to clinical decision
Tidsramme: first 24 hs.
Time from patient admission to the clinical decision (admission for further testing or discharge from the ER) between the two arms.
first 24 hs.

Samarbejdspartnere og efterforskere

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

Sponsor

José Ortiz

Samarbejdspartnere

Instituto de Salud Carlos III

Efterforskere

  • Ledende efterforsker: José T Ortiz-Perez, MD, PhD, Hospital Clinic of Barcelona

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. januar 2010

Primær færdiggørelse (Faktiske)

1. oktober 2013

Studieafslutning (Faktiske)

1. oktober 2013

Datoer for studieregistrering

Først indsendt

6. september 2012

Først indsendt, der opfyldte QC-kriterier

6. september 2012

Først opslået (Skøn)

10. september 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. oktober 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. oktober 2013

Sidst verificeret

1. oktober 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PI09/90513

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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