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

20 februari 2020 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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).

Studietyp

Observationell

Inskrivning (Faktisk)

467

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Quebec
      • Montreal, Quebec, Kanada
        • Montreal Heart Institute

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 87 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall accuracy of "significant coronary artery disease (CAD)" according to non-invasive imaging modality
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

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

Andra resultatmått

Resultatmått
Tidsram
Specificity of "high-risk CAD" according to non-invasive imaging modality flow and FFR
Tidsram: baseline
baseline
Positive predictive value of "high-risk CAD" according to non-invasive imaging modality flow and FFR
Tidsram: baseline
baseline
Negative predictive value of "high-risk CAD" according to non-invasive imaging modality flow and FFR
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: baseline
baseline

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2012

Primärt slutförande (Faktisk)

1 maj 2018

Avslutad studie (Faktisk)

18 april 2019

Studieregistreringsdatum

Först inskickad

18 juli 2013

Först inskickad som uppfyllde QC-kriterierna

24 oktober 2013

Första postat (Uppskatta)

30 oktober 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

21 februari 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

20 februari 2020

Senast verifierad

1 februari 2020

Mer information

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OBESLUTSAM

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