Impact of Stress CT Myocardial Perfusion on Downstream Resources and Prognosis (CTP-PRO)
2019年6月4日 更新者：Gianluca Pontone, MD, PhD、Centro Cardiologico Monzino
Impact of Stress Cardiac Computed Tomography Myocardial Perfusion on Downstream Resources and PROgnosis in Patients With Suspected or Known Coronary Artery Disease: a Multicenter International Study
CT myocardial perfusion imaging (CTP) represents one of the newly developed CT-based techniques but its cost-effectiveness in the clinical pathway is undefined.
The aim of the study is to evaluate the usefulness of combined evaluation of coronary anatomy and myocardial perfusion in intermediate to high-risk patients for suspected CAD or with known disease in terms of clinical decision-making, resource utilization and outcomes in a broad variety of geographic areas and patient subgroups.
調査の概要
状態
わからない
詳細な説明
The use of cardiac computed tomography angiography (CCTA) is usually suggested in low to intermediate risk for its diagnostic and prognostic role to rule out CAD with low radiation exposure. In the setting of intermediate to high risk patients, the addition of functional information is prognostically useful and, in patients with previous history of percutaneous coronary intervention (PCI), functional strategy has been shown to be more cost-effective as compared to anatomical assessment CT myocardial perfusion imaging (CTP) represents one of the newly developed CT-based techniques, combining both anatomical and functional evaluation of CAD in a single imaging modality. More recently, stress CTP was shown to provide additional diagnostic value as compared to CCTA alone in intermediate to high risk patients. The purpose of this study will be to evaluate the usefulness and impact of combined evaluation of coronary artery anatomy and myocardial perfusion with CCTA+CTP in intermediate to high risk patients for suspected CAD or with known disease in terms of clinical decision-making, resource utilization, and outcomes in a broad variety of geographic areas and patient subgroups.
CTP-PRO study is a cooperative, international, multicentre, prospective, open-label, randomized controlled study evaluating the cost-effectiveness of a CCTA+CTP strategy versus usual care in intermediate to high risk patients with suspected or known CAD who undergo clinically indicated diagnostic evaluation.
Patients will be screened for study eligibility. Patients meeting all selection criteria will be asked to sign an informed consent document prior to undergoing any study-specific evaluation; then a structured interview will be performed and a clinical history obtained, assessing the presence of common cardiac risk factors, drug therapy (focus on statin, aspirin and/or antiplatelet agent use) and symptoms (typical or atypical angina, to estimate the pre-test likelihood of CAD).
Upon completion of the screening procedure and enrollment, the patients will be randomized 1:1 to the CT-based strategy (Group A) or usual care (Group B). Patient follow-up will be performed at 1 year (± 1 month) and 2 years (± 1 month) by trained interviewers who check medical records or by phone interview collecting the following information: downstream testing; overall radiation exposure; outcomes; cost-effectiveness estimation.
The primary endpoint of the study is the reclassification rate of CCTA in group B due to the addition of CTP. The secondary endpoint will be the comparison between group A and group B in terms of non-invasive and invasive downstream testing, prevalence of obstructive CAD at ICA, revascularization, cumulative ED and overall cost during the follow-up at 1- and 2-years. The tertiary endpoint will be the comparison between each group in terms of MACE and cost-effectiveness at 1- and 2-years.
研究の種類
介入
入学 (予想される)
2000
段階
- 適用できない
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。
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年歳以上 (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
説明
Inclusion Criteria:
- Consecutive patients (age ≥ 18 years) with known or suspected CAD referred for clinically indicated diagnostic evaluation.
- CCTA has to be performed with the state of art in terms of scanner technology as follow: Revolution CT (GE Healthcare, Milwaukee, WI), CardioGraphe (Arineta, Caesarea, Israel), SOMATOM Force (Siemens, Forchheim, Germany), Brilliance iCT and IQon CT (Philips, Best, Netherlands), Aquilion One Vision (Toshiba Medical Systems Corp., Otawara, Japan).
Exclusion Criteria:
- Performance of any non-invasive diagnostic testing within 90 days before enrollment
- Low to intermediate pre-test likelihood of CAD according to the updated Diamond-Forrester risk model score
- Acute coronary syndrome
- Need for an emergent procedure
- Evidence of clinical instability
- Contra-indication to contrast agent administration and/or impaired renal function
- Inability to sustain a breath hold
- Pregnancy
- Cardiac arrhythmias
- Presence of pace maker or implantable cardioverter defibrillator
- Contra-indications to the administration of sub-lingual nitrates, beta-blockade and adenosine
- Structural cardiomyopathy outside of suspected or know ischemic heart disease
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
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：CCTA Strategy
CCTA will be performed with one of the latest generation scanners.
A stenosis > 50% will be considered as significant from an anatomical point of view.
For coronary stents, degree of intrastent restenosis will be evaluated by visual assessment of intraluminal contrast density.
ISR > 50% will be considered as significant from an anatomical point of view.
For CABG, each graft will be visually evaluated and scored as patent, non-significant stenosis ≤ 50%, significant stenosis > 50%, or occluded.
For patients with positive CCTA results, additional stress CTP will be performed subsequently.
If indicated, vasodilatation will be induced with i.v.
adenosine injection or regadenoson.
Static or dynamic CTP will be performed according to local practice and scanner technology available.
For all patients with previous history of MI the presence of reversible ischemia will be obtained by the comparison between rest and stress perfusion.
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When judged indicated, functional assessment with stress CTP perfusion will be performed on top of CCTA.
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アクティブコンパレータ：Standard of care Strategy
Patients randomized to this group will be evaluated according to current clinical guidelines with the following approaches: (a) stress ECG, or imaging-based tests such as Stress Echo, Stress CMR, SPECT or PET; (b) direct referral to ICA.
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(a) functional non-invasive tests (stress ECG, or imaging-based tests such as Stress Echo, Stress CMR, SPECT or PET) as a gatekeeper for ICA; (b) direct referral to ICA.
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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 |
|---|---|---|
|
Reclassification rate of CCTA in group B due to the addition of CTP
時間枠：30 days.
|
For each enrolled patient in whom both CCTA and stress CTP will be performed, the endpoint review committee will use data from coronary CTA and CTP, along with the clinical data to determine the management plan using the following criteria: (a) optimal medical therapy, (b) more non-invasive information required, (c) invasive evaluation required, (d) revascularization treatment (PCI or CABG or hybrid treatment).
|
30 days.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Downstream non-invasive testing
時間枠：1- and 2-years.
|
Comparison between group A and group B in terms of number of non-invasive downstream testing (Exercise EKG, Stress-Echo, SPECT, Stress CMR, PET) or invasive testing (invasive coronary angiography) performed after the randomization.
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1- and 2-years.
|
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Downstream invasive testing
時間枠：1- and 2-years.
|
Comparison between group A and group B in terms of number of downstream invasive testing (invasive coronary angiography) performed after the randomization.
|
1- and 2-years.
|
|
Prevalence of obstructive CAD at ICA
時間枠：1- and 2-years.
|
Comparison between group A and group B in terms of number of patients with obstructive CAD at ICA.
|
1- and 2-years.
|
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Revascularization
時間枠：1- and 2-years.
|
Comparison between group A and group B in terms of number of patients treated with revascularization (PCI or CABG or hybrid treatment).
|
1- and 2-years.
|
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Effective Dose
時間枠：1- and 2-years.
|
Comparison between group A and group B in terms of cumulative Effective Dose (ED), measured in mSv, due to non-invasive or invasive testing performed after randomization.
|
1- and 2-years.
|
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Overall costs related to downstream diagnostic tests.
時間枠：1- and 2-years.
|
Comparison between group A and group B in terms of overall costs of downstream diagnostic tests (sum of costs of all diagnostic tests performed after randomization), expressed in Dollars, according to local reimbursement.
|
1- and 2-years.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Hospitalization for cardiac reason
時間枠：1- and 2-years.
|
Comparison between group A and group B group in terms of number of patients that needed hospitalization for cardiac reason.
|
1- and 2-years.
|
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Unstable angina
時間枠：1- and 2-years.
|
Comparison between group A and group B group in terms of number of patients that needed hospitalization for unstable angina (defined according to 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation.
Eur Heart J 2016:37,267-315).
|
1- and 2-years.
|
|
Non-fatal myocardial infarction
時間枠：1- and 2-years.
|
Comparison between group A and group B group in terms of number of patients that experienced non-fatal myocardial infarction (defined according to Fourth universal definition of myocardial infarction, 2018.
Eur Heart J 2019:40,237-269).
|
1- and 2-years.
|
|
Cardiac death
時間枠：1- and 2-years.
|
Comparison between group A and group B group in terms of number of patients that experienced death because of immediate cardiac cause (e.g., MI, low-output failure, fatal arrhythmia) or vascular cause (e.g., cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause).
Unwitnessed death and death of unknown cause will be classified as cardiovascular death.
|
1- and 2-years.
|
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MACE (Major adverse cardiovascular events)
時間枠：1- and 2-years.
|
MACE will be defined as a combined endpoint of unstable angina, nonfatal MI, and cardiac death.
|
1- and 2-years.
|
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Cost-effectiveness ratio
時間枠：1- and 2-years.
|
Cost-effectiveness ratio will be calculated according to the following equation: (Index test cost + downstream diagnostic tests cost) / projected remaining life expectancy.
|
1- and 2-years.
|
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。
協力者
捜査官
- 主任研究者：U. Joseph Schoepf, MD、Medical University of South Carolina
- 主任研究者：Gianluca Pontone, MD, PhD、Centro Cardiologico Monzino, IRCCS
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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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 (予想される)
2019年6月1日
一次修了 (予想される)
2022年6月1日
研究の完了 (予想される)
2022年10月1日
試験登録日
最初に提出
2019年5月30日
QC基準を満たした最初の提出物
2019年6月4日
最初の投稿 (実際)
2019年6月6日
学習記録の更新
投稿された最後の更新 (実際)
2019年6月6日
QC基準を満たした最後の更新が送信されました
2019年6月4日
最終確認日
2019年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。