Impact of Hyperemic State on Angio-IMR Performance
The Impact of Hyperemic State on the Performance of Angiography Derived Indices in Assessing Coronary Microvascular Disease
The goal of this observational study is to evaluate the diagnostic performance of angiography-derived microcirculatory indices (Angio-IMR) in assessing patients with stable angina or suspected coronary artery disease. The main questions it aims to answer are:
How do the numerical values of Angio-IMR from five different software vendors change across three physiological states (resting, sub-hyperemia induced by nitroglycerin, and maximal hyperemia induced by adenosine)? Which physiological state and software algorithm provide the highest diagnostic accuracy (Area Under the Curve, AUC) for diagnosing Coronary Microvascular Disease (CMD) when compared to the gold standard wire-based IMR? Researchers will compare the Angio-IMR results calculated under the three different physiological conditions within the same patient to see how the hyperemic state impacts the performance and consistency of these non-invasive indices.
Participants will:
Undergo standard-of-care coronary angiography and physiological assessment using a pressure wire for index of microvascular resistance (Wire-IMR) as part of their clinical management.
Have their angiographic images captured at three specific time points: at rest, after intracoronary nitroglycerin, and during adenosine-induced maximal hyperemia.
Allow their de-identified imaging and clinical data to be analyzed by an independent core laboratory using five different Angio-IMR software platforms to evaluate microvascular function.
調査の概要
詳細な説明
Study Overview and Procedural Protocol
This is a prospective, multi-center, diagnostic accuracy study employing a self-controlled design. All participants will undergo coronary angiography and physiological assessment according to standard clinical indications. During the procedure, specific angiographic images will be systematically captured for the target vessel at three distinct physiological time points:
Resting State: Baseline coronary angiography without any hyperemic agents. Sub-hyperemic State: Following the intracoronary administration of nitroglycerin.
Maximal Hyperemic State: During continuous intracoronary infusion of adenosine to achieve maximal microvascular vasodilation.
Immediately following image acquisition, the reference standard measurement-Wire-IMR-will be performed using a pressure-sensor-equipped guidewire under maximal hyperemia.
Core Laboratory Imaging Analysis and Blinding
All angiographic data will be de-identified and transferred to a centralized, independent Cardiovascular Imaging Core Laboratory at Zhongshan Hospital, Fudan University. The analysis will be conducted as follows:
Software Platforms: Five different commercially available Angio-IMR software platforms (anonymized as A, B, C, D, and E) will be used to calculate microvascular resistance.
Independent Analysis: Five dedicated analysts, each specialized in one specific software platform, will perform the calculations. Each analyst will be blinded to the patients' clinical information, the Wire-IMR gold standard results, and the results from the other four software platforms.
Standardization: A primary researcher, not involved in the software measurements, will pre-define the target vessel segments and measurement frames to ensure consistency across all five software platforms.
Statistical Considerations and Data Management The study aims to determine if the coronary hyperemic state significantly alters the fluid dynamics modeling utilized by Angio-IMR algorithms. AUC will be calculated for each software at each of the three states. A head-to-head comparison of AUCs will be performed using DeLong's test. To maintain data integrity, results from the core laboratory and the clinical centers will remain strictly separated until the final database lock.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Jinying Zhou, MD, PhD
- メール：zhou.jinying@zs-hospital.sh.cn
研究連絡先のバックアップ
- 名前：Chenguang Li, MD, PhD
- 電話番号：021 6404 1990
- メール：li.chenguang@zs-hospital.sh.cn
研究場所
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Guangzhou、中国
- 募集
- The First Affiliated Hospital, Sun Yat-sen University
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コンタクト：
- Xun Hu, MD, PhD
- 電話番号：020-87608185
- メール：hxun@mail.sysu.edu.cn
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Please Select
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Shanghai、Please Select、中国、200000
- 募集
- Zhongshan Hospital, Fudan University
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コンタクト：
- Jinying Zhou, MD, PhD
- 電話番号：021 6404 1990
- メール：zhou.jinying@zs-hospital.sh.cn
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
The study population consists of adult patients (aged 18 and older) clinically diagnosed with stable angina or suspected coronary artery disease who are scheduled to undergo conventional coronary angiography and invasive physiological assessment.
Participants are prospectively and consecutively recruited from multiple clinical centers in China. The population specifically targets individuals with non-obstructive coronary arteries (stenosis < 50%) or those with moderate stenosis (50%-90%) but preserved epicardial flow (FFR > 0.80), where assessment of coronary microvascular function is clinically indicated to investigate the cause of ischemia.
説明
Inclusion Criteria:
- Stable angina or suspected coronary heart disease.
- Scheduled for coronary angiography and physiological assessment.
- Target vessel with stenosis < 50% or 50%-90% with fractional flow reserve (FFR) > 0.80.
- Provided informed consent.
Exclusion Criteria:
- Hemodynamic instability (acute myocardial infarction, cardiogenic shock, severe arrhythmia).
- Contraindications to angiography (e.g., end-stage renal disease).
- Contraindications to adenosine (e.g., severe asthma, high-degree atrial-ventricular block).
- Life expectancy < 1 year or pregnancy.
- Target vessel unsuitable for wire operation (left main lesion, severe tortuosity) or stenosis > 90%.
研究計画
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 |
介入・治療 |
|---|---|
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Single cohort, self-controlled
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Unlike the reference standard "Wire-IMR," which requires the advancement of a specialized pressure-sensor guidewire into the distal coronary artery, Angio-IMR is a wire-free technology.
It derives microvascular resistance indices purely through computational fluid dynamics (CFD) or specialized mathematical models based on standard coronary angiographic projections.
This eliminates the risk of wire-induced vascular injury or spasm.
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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 |
|---|---|---|
|
Area Under the ROC Curve (AUC)
時間枠：Baseline
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Comparison of AUC for 5 types of Angio-IMR against Wire-IMR (Gold standard, CMD defined as Wire-IMR ≥ 25) under three states.
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Baseline
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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 |
|---|---|---|
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Diagnostic Accuracy
時間枠：Baseline
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Sensitivity, specificity, positive predictive value, negative predictive value.
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Baseline
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Correlation
時間枠：Baseline
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Pearson/Spearman coefficients between Angio-IMR and Wire-IMR.
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Baseline
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Agreement
時間枠：Baseline
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Bland-Altman analysis (Bias and Limits of Agreement).
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Baseline
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Inter-vendor Agreement
時間枠：Baseline
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Consistency between different software brands.
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Baseline
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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。
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