Non-isotope Based Imaging Modalities vs Technetium-99m Single-Photon Emission Computed Tomography(99mTcSPECT) (MITNECB5)
2020年2月20日 更新者：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.
調査の概要
状態
完了
条件
詳細な説明
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).
研究の種類
観察的
入学 (実際)
467
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Quebec
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Montreal、Quebec、カナダ
- Montreal Heart Institute
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～87年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Overall accuracy of "significant coronary artery disease (CAD)" according to non-invasive imaging modality
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Overall accuracy of "high-risk CAD" according to non-invasive imaging modality flow and FFR
時間枠：baseline
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baseline
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Sensitivity of "high-risk CAD" according to non-invasive imaging modality flow and FFR
時間枠：Baseline
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Baseline
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その他の成果指標
結果測定 |
時間枠 |
|---|---|
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Specificity of "high-risk CAD" according to non-invasive imaging modality flow and FFR
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：baseline
|
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)
時間枠：baseline
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baseline
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Jean-Claude Tardif, M.D、Montreal Heart Institute
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2012年10月1日
一次修了 (実際)
2018年5月1日
研究の完了 (実際)
2019年4月18日
試験登録日
最初に提出
2013年7月18日
QC基準を満たした最初の提出物
2013年10月24日
最初の投稿 (見積もり)
2013年10月30日
学習記録の更新
投稿された最後の更新 (実際)
2020年2月21日
QC基準を満たした最後の更新が送信されました
2020年2月20日
最終確認日
2020年2月1日
詳しくは
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