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Non-isotope Based Imaging Modalities vs Technetium-99m Single-Photon Emission Computed Tomography(99mTcSPECT) (MITNECB5)

20. februar 2020 oppdatert av: Montreal Heart Institute

Non-isotope Based Imaging Modalities vs 99mTcSPECT to Detect Myocardial Ischemia in Patients at High Risk for Ischemic Cardiovascular Events

SPECT is currently the dominant clinical test for diagnostic and prognostic purposes as well as therapeutic decision-making. Given the shortage of nuclear reactor-produced Tc, advancing the use of non-isotope based imaging modalities has the potential to change the standard of care for patients with CAD as each one of these technics (CMR, CT, Stress echocardiography) has its own distinct potential advantages over SPECT.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

Obtain a better understanding of the clinical utility of advanced non-isotope-based imaging modalities to detect relevant CAD as potential alternatives to SPECT. Approximately 450 subjects will be enrolled in total. Three groups of about 150 patients per group. Each group will undergo imaging with 2 modalities; Group 1: 99mTcSPECT plus CMR, Group 2: 99mTcSPECT plus CT, Group 3:99mTcSPECT plus stress echocardiography. All 450 patients will undergo standard invasive coronary angiography following completion of non-invasive imaging, except for patients in whom both nuclear and non-nuclear imaging modalities reveal a normal result confirming the absence of significant coronary artery disease (i.e invasive angiography would not be clinically indicated and FFR would be considered to be above 0.8). Thrombolysis in Myocardial Infraction (TIMI) flow will be measured in all patients undergoing angiography, and fractional flow reserve (FFR) will be measured in all patients except those with TIMI flow =0, 1 and 2. All imaging procedures must be completed within 6 weeks. All patients will have a follow-up visit at 6 months after enrollment. During the 6 month follow-up visit major adverse cardiovascular events will be collected and adjudicated by a clinical endpoint committee (CEC).

Studietype

Observasjonsmessig

Registrering (Faktiske)

467

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Quebec
      • Montreal, Quebec, Canada
        • Montreal Heart Institute

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 87 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Approximately 450 patients across Canada. Patients will be identified after a clinically indicated SPECT for evaluation of myocardial ischemia.The investigator will assign the patient in one of the three groups based on his medical assessment and availability of equipment at the centre.

Beskrivelse

Inclusion Criteria:

  • clinically indicated request for SPECT
  • ability to undergo at least one of three non-nuclear imaging tests; CMR, CT or Stress Echocardiography
  • History of recent symptoms suggestive of myocardial ischemia
  • High risk for ischemic cardiovascular events

Exclusion Criteria:

  • severely reduced systolic function (LV ejection fraction less than 35%)
  • Recent (less than 3 days) acute coronary syndrome including acute myocardial infarction
  • contraindications to dipyridamole SPECT including : i)severe reactive airway disease; ii) less than 3 days post Myocardial Infarction - Acute Coronary Syndrome (MI-ACS); iii) high-grade Atrioventricular block (AV block); iv)allergy to dipyridamole or theophylline; v) caffeine within 12 hours; vi) theophylline use within 48 hours; vii) severe claustrophobia; or viii) women who may be pregnant
  • kidney dysfunction (i.e estimated Glomerular Filtration Rate (eGFR) less than 45)
  • use of investigational drug or device within 30 days of screening visit
  • Coronary Artery Bypass Graft(s) surgery (CABG)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Diagnosis
Group 3: 99mTCSPECT plus stress echocardiography
group 1 : diagnosis
Group 1: 99mTcSPECT plus CMR
Group 2: diagnosis
Group 2: 99mTcSPECT plus CT

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall accuracy of "significant coronary artery disease (CAD)" according to non-invasive imaging modality
Tidsramme: baseline
The overall accuracy is calculated as the probability that a subject is correctly classified (presence of significant CAD or not) by non-invasive imaging modality. The standard of truth is presence of significant CAD or not according to the invasive fractional flow reserve (FFR)
baseline
Sensitivity of "significant CAD" according to non-invasive imaging modality
Tidsramme: baseline
The sensitivity is calculated as the probability that a subject with presence of significant CAD according to FFR is correctly identified as such by non-invasive imaging modality
baseline
Specificity of "significant CAD" according to non-invasive imaging modality
Tidsramme: baseline
The specificity is calculated as the probability that a subject with absence of significant CAD according to FFR is correctly identified as such by non-invasive imaging modality
baseline
Positive predictive value of "significant CAD" according to non-invasive imaging modality
Tidsramme: baseline
The positive predictive value is calculated as the probability that a subject with presence of significant CAD according to non-invasive imaging modality truly have significant CAD according to FFR
baseline
Negative predictive value of "significant CAD" according to non-invasive imaging modality
Tidsramme: Baseline
The negative predictive value is calculated as the probability that a subject with absence of significant CAD according to non-invasive imaging modality truly does not have significant CAD according to FFR
Baseline

Sekundære resultatmål

Resultatmål
Tidsramme
Overall accuracy of "high-risk CAD" according to non-invasive imaging modality flow and FFR
Tidsramme: baseline
baseline
Sensitivity of "high-risk CAD" according to non-invasive imaging modality flow and FFR
Tidsramme: Baseline
Baseline

Andre resultatmål

Resultatmål
Tidsramme
Specificity of "high-risk CAD" according to non-invasive imaging modality flow and FFR
Tidsramme: baseline
baseline
Positive predictive value of "high-risk CAD" according to non-invasive imaging modality flow and FFR
Tidsramme: baseline
baseline
Negative predictive value of "high-risk CAD" according to non-invasive imaging modality flow and FFR
Tidsramme: baseline
baseline
Overall accuracy of "high-risk CAD" according to non-invasive imaging modality to predict occurrence of the composite clinical endpoint of major adverse cardiovascular events (MACE)
Tidsramme: baseline
baseline
Sensitivity of "high-risk CAD" according to non-invasive imaging modality to predict occurrence of the composite clinical endpoint of major adverse cardiovascular events (MACE)
Tidsramme: baseline
baseline
Specificity of "high-risk CAD" according to non-invasive imaging modality to predict occurrence of the composite clinical endpoint of major adverse cardiovascular events (MACE)
Tidsramme: baseline
baseline
Positive predictive value of "high-risk CAD" according to non-invasive imaging modality to predict occurrence of the composite clinical endpoint of major adverse cardiovascular events (MACE)
Tidsramme: baseline
baseline
Negative predictive value of "high-risk CAD" according to non-invasive imaging modality to predict occurrence of the composite clinical endpoint of major adverse cardiovascular events (MACE)
Tidsramme: baseline
baseline

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Jean-Claude Tardif, M.D, Montreal Heart Institute

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2012

Primær fullføring (Faktiske)

1. mai 2018

Studiet fullført (Faktiske)

18. april 2019

Datoer for studieregistrering

Først innsendt

18. juli 2013

Først innsendt som oppfylte QC-kriteriene

24. oktober 2013

Først lagt ut (Anslag)

30. oktober 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. februar 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. februar 2020

Sist bekreftet

1. februar 2020

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

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