Non-isotope Based Imaging Modalities vs Technetium-99m Single-Photon Emission Computed Tomography(99mTcSPECT) (MITNECB5)
20 februari 2020 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
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
Observationeel
Inschrijving (Werkelijk)
467
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Quebec
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Montreal, Quebec, Canada
- Montreal Heart Institute
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 87 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
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)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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Diagnosis
Group 3: 99mTCSPECT plus stress echocardiography
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group 1 : diagnosis
Group 1: 99mTcSPECT plus CMR
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Group 2: diagnosis
Group 2: 99mTcSPECT plus CT
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Overall accuracy of "significant coronary artery disease (CAD)" according to non-invasive imaging modality
Tijdsspanne: baseline
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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)
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baseline
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Sensitivity of "significant CAD" according to non-invasive imaging modality
Tijdsspanne: baseline
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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
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baseline
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Specificity of "significant CAD" according to non-invasive imaging modality
Tijdsspanne: baseline
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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
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baseline
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Positive predictive value of "significant CAD" according to non-invasive imaging modality
Tijdsspanne: baseline
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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
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baseline
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Negative predictive value of "significant CAD" according to non-invasive imaging modality
Tijdsspanne: Baseline
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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
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Baseline
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Overall accuracy of "high-risk CAD" according to non-invasive imaging modality flow and FFR
Tijdsspanne: baseline
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baseline
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Sensitivity of "high-risk CAD" according to non-invasive imaging modality flow and FFR
Tijdsspanne: Baseline
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Baseline
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Andere uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Specificity of "high-risk CAD" according to non-invasive imaging modality flow and FFR
Tijdsspanne: baseline
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baseline
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Positive predictive value of "high-risk CAD" according to non-invasive imaging modality flow and FFR
Tijdsspanne: baseline
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baseline
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Negative predictive value of "high-risk CAD" according to non-invasive imaging modality flow and FFR
Tijdsspanne: baseline
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baseline
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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)
Tijdsspanne: baseline
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baseline
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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)
Tijdsspanne: baseline
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baseline
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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)
Tijdsspanne: baseline
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baseline
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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)
Tijdsspanne: baseline
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baseline
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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)
Tijdsspanne: baseline
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baseline
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Jean-Claude Tardif, M.D, Montreal Heart Institute
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 oktober 2012
Primaire voltooiing (Werkelijk)
1 mei 2018
Studie voltooiing (Werkelijk)
18 april 2019
Studieregistratiedata
Eerst ingediend
18 juli 2013
Eerst ingediend dat voldeed aan de QC-criteria
24 oktober 2013
Eerst geplaatst (Schatting)
30 oktober 2013
Updates van studierecords
Laatste update geplaatst (Werkelijk)
21 februari 2020
Laatste update ingediend die voldeed aan QC-criteria
20 februari 2020
Laatst geverifieerd
1 februari 2020
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- MITNEC B5
Plan Individuele Deelnemersgegevens (IPD)
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ONBESLIST
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