Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women (ANOCA-UY)
Invasive Functional and Morphological Coronary Assessment Followed by Phenotype-Guided Multidisciplinary Treatment in Women With Angina and Non-Obstructive Coronary Arteries: A Prospective Single-Center Interventional Study
This prospective single-center interventional study will include women with angina and non-obstructive coronary arteries. Participants will undergo a standardized invasive coronary assessment combining coronary physiology, acetylcholine provocation testing, and optical coherence tomography. The diagnostic protocol will identify functional and morphological mechanisms of angina, including microvascular dysfunction, epicardial vasospasm, microvascular spasm, endothelial dysfunction, functional epicardial disease, combined mechanisms, or normal coronary physiology.
Based on the identified phenotype, participants will receive individualized multidisciplinary treatment, including targeted pharmacological therapy, adapted cardiovascular rehabilitation, and psycho-emotional support when indicated. Clinical follow-up will be performed at 1, 6, and 12 months to assess angina symptoms, quality of life, functional capacity, adherence to treatment, and cardiovascular events.
調査の概要
状態
詳細な説明
Angina with non-obstructive coronary arteries (ANOCA) is a prevalent and frequently underdiagnosed clinical condition, particularly in women. Although obstructive epicardial coronary artery disease is absent, symptoms may be related to coronary microvascular dysfunction, epicardial or microvascular vasospasm, endothelial dysfunction, non-obstructive atherosclerotic plaque, myocardial bridging, or combined mechanisms. In routine clinical practice, many patients remain without a precise pathophysiological diagnosis after conventional angiography.
This study will evaluate a structured diagnostic and therapeutic pathway for women with ANOCA at a single academic cardiovascular center in Uruguay. Eligible participants will undergo an invasive coronary assessment performed during cardiac catheterization. The protocol will include angiographic confirmation of non-obstructive coronary arteries, invasive coronary physiology assessment, acetylcholine provocation testing for coronary vasomotor disorders, and optical coherence tomography for intracoronary morphological assessment.
The invasive findings will be integrated to classify participants according to their predominant functional and/or morphological phenotype. Potential phenotypes include coronary microvascular dysfunction, epicardial vasospasm, microvascular spasm, endothelial dysfunction, functional epicardial disease, non-obstructive plaque-related abnormalities, combined mechanisms, or normal invasive coronary physiology.
After phenotyping, participants will receive an individualized treatment plan according to the identified mechanism. This may include targeted pharmacological therapy, cardiovascular risk factor optimization, adapted cardiovascular rehabilitation, and structured psycho-emotional support when clinically indicated. The therapeutic strategy will be determined by the treating clinical team according to the study protocol and current evidence-based recommendations.
Participants will be followed for 12 months after the invasive assessment. Follow-up visits will assess angina symptoms, health-related quality of life, functional capacity, treatment adherence, adverse events, and cardiovascular outcomes. The study aims to generate local evidence on the feasibility and clinical utility of a phenotype-guided approach for women with ANOCA and to support the development of a multidisciplinary reference pathway for this condition in Uruguay.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Rafael Mila, MD
- 電話番号：9 +59824871515
- メール：r1000a@gmail.com
研究連絡先のバックアップ
- 名前：Victor Dayan, MD, PhD
- 電話番号：9 +5989924871515
- メール：victordayan24@gmail.com
研究場所
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Montevideo Department
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Montevideo、Montevideo Department、ウルグアイ、11600
- Hospital de Clínicas Dr. Manuel Quintela
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コンタクト：
- Rafael Mila, MD
- 電話番号：+59824875201
- メール：cencar@hc.edu.uy
-
コンタクト：
- Victor Dayan, MD, PhD
- 電話番号：+59824875201
- メール：cencar@hc.edu.uy
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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
説明
Inclusion Criteria:
- Female participants aged 35 to 75 years.
- Symptoms compatible with stable angina or suspected myocardial ischemia.
- Non-obstructive coronary arteries, defined as absence of angiographic stenosis greater than or equal to 50%.
- Ability to undergo invasive coronary assessment and clinical follow-up.
- Written informed consent.
Exclusion Criteria:
- Significant structural heart disease.
- Severe left ventricular systolic dysfunction, defined as left ventricular ejection fraction <40%.
- Clinically relevant contraindication to adenosine or acetylcholine, including severe asthma, untreated high-grade atrioventricular block, or known hypersensitivity.
- Active oncological disease or life expectancy less than 12 months.
- Inability to complete the diagnostic or therapeutic study protocol.
- Participation in another clinical study that could interfere with the present protocol.
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
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
|
実験的：Phenotype-Guided Diagnostic and Therapeutic Strategy
Participants will undergo a standardized invasive coronary assessment to identify functional and morphological mechanisms of angina with non-obstructive coronary arteries.
Based on the identified phenotype, participants will receive individualized treatment including targeted pharmacological therapy, adapted cardiovascular rehabilitation, and psycho-emotional support when clinically indicated.
|
Participants will undergo invasive coronary assessment including coronary physiology measurements, acetylcholine provocation testing, and optical coherence tomography to identify functional and morphological mechanisms of angina with non-obstructive coronary arteries.
Pharmacological treatment will be individualized according to the invasive coronary phenotype identified.
Treatment may include antianginal therapy, vasodilator therapy, endothelial function-targeted therapy, cardiovascular risk factor optimization, or revascularization evaluation when clinically indicated.
|
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 |
|---|---|---|
|
Change in Angina-Related Health Status Assessed by the Seattle Angina Questionnaire-7
時間枠：Baseline to 12 months
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Change in Seattle Angina Questionnaire-7 score from baseline to 12-month follow-up after invasive coronary phenotyping and phenotype-guided multidisciplinary treatment.
The Seattle Angina Questionnaire-7 is a 7-item patient-reported outcome measure assessing angina-related health status.
Scores range from 0 to 100, with higher scores indicating better angina-related health status and fewer symptoms.
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Baseline to 12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Health-Related Quality of Life Assessed by the EuroQol 5-Dimension 5-Level Visual Analog Scale
時間枠：Baseline to 12 months
|
Change in EuroQol 5-Dimension 5-Level Visual Analog Scale score from baseline to 12-month follow-up.
The EuroQol 5-Dimension 5-Level Visual Analog Scale is a patient-reported measure of overall health status.
Scores range from 0 to 100, with higher scores indicating better self-reported health.
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Baseline to 12 months
|
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Change in Functional Capacity
時間枠：Baseline to 12 months
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Change in functional capacity assessed by six-minute walk test distance or exercise testing parameters, according to the local study protocol.
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Baseline to 12 months
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Prevalence of Invasive Coronary Functional Phenotypes
時間枠：At index invasive coronary procedure
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Proportion of participants classified as having coronary microvascular dysfunction, epicardial vasospasm, microvascular spasm, endothelial dysfunction, functional epicardial disease, combined mechanisms, or normal invasive coronary physiology.
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At index invasive coronary procedure
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Prevalence of Coronary Morphological Abnormalities Assessed by Optical Coherence Tomography
時間枠：At index invasive coronary procedure
|
Proportion of participants with non-obstructive atherosclerotic plaque, plaque rupture, plaque erosion, thin-cap fibroatheroma, macrophage accumulation, positive remodeling, myocardial bridging, spontaneous coronary artery dissection, or other optical coherence tomography findings.
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At index invasive coronary procedure
|
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Change in Perceived Stress Assessed by the Perceived Stress Scale-4
時間枠：Baseline to 6 and 12 months
|
Change in Perceived Stress Scale-4 score from baseline to 6-month and 12-month follow-up.
The Perceived Stress Scale-4 is a 4-item patient-reported measure of perceived stress during the previous month.
Total scores range from 0 to 16, with higher scores indicating greater perceived stress and a worse outcome.
|
Baseline to 6 and 12 months
|
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Medication Adherence Assessed by the Modified Morisky-Green-Levine Questionnaire
時間枠：1, 6, and 12 months
|
Medication adherence will be assessed using the modified Morisky-Green-Levine questionnaire at 1, 6, and 12 months.
The modified Morisky-Green-Levine questionnaire is a patient-reported measure of medication adherence.
Scores range from 0 to 4, with higher scores indicating better medication adherence.
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1, 6, and 12 months
|
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Major Adverse Cardiovascular Events
時間枠：Baseline to 12 months
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Composite of death, myocardial infarction, hospitalization for cardiovascular causes, or coronary revascularization during follow-up.
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Baseline to 12 months
|
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Adherence to Cardiovascular Rehabilitation Assessed by Session Completion Rate
時間枠：During the 12-week cardiovascular rehabilitation program.
|
Adherence to cardiovascular rehabilitation will be assessed at 1, 6, and 12 months as the percentage of prescribed rehabilitation sessions completed.
Higher percentages indicate better adherence.
Adherence will be defined as completion of at least 75% of prescribed sessions.
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During the 12-week cardiovascular rehabilitation program.
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Adherence to Psycho-Emotional Support Assessed by Session Completion Rate
時間枠：1, 6, and 12 months
|
Adherence to psycho-emotional support will be assessed at 1, 6, and 12 months as the percentage of prescribed sessions completed among participants for whom this intervention is clinically indicated.
Higher percentages indicate better adherence.
Adherence will be defined as completion of at least 75% of prescribed sessions.
|
1, 6, and 12 months
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Ford TJ, Stanley B, Good R, Rocchiccioli P, McEntegart M, Watkins S, Eteiba H, Shaukat A, Lindsay M, Robertson K, Hood S, McGeoch R, McDade R, Yii E, Sidik N, McCartney P, Corcoran D, Collison D, Rush C, McConnachie A, Touyz RM, Oldroyd KG, Berry C. Stratified Medical Therapy Using Invasive Coronary Function Testing in Angina: The CorMicA Trial. J Am Coll Cardiol. 2018 Dec 11;72(23 Pt A):2841-2855. doi: 10.1016/j.jacc.2018.09.006. Epub 2018 Sep 25.
- Vrints C, Andreotti F, Koskinas KC, Rossello X, Adamo M, Ainslie J, Banning AP, Budaj A, Buechel RR, Chiariello GA, Chieffo A, Christodorescu RM, Deaton C, Doenst T, Jones HW, Kunadian V, Mehilli J, Milojevic M, Piek JJ, Pugliese F, Rubboli A, Semb AG, Senior R, Ten Berg JM, Van Belle E, Van Craenenbroeck EM, Vidal-Perez R, Winther S; ESC Scientific Document Group. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J. 2024 Sep 29;45(36):3415-3537. doi: 10.1093/eurheartj/ehae177. No abstract available.
- Smilowitz NR, Prasad M, Widmer RJ, Toleva O, Quesada O, Sutton NR, Lerman A, Reynolds HR, Kesarwani M, Savage MP, Sweeny JM, Janaszek KB, Barseghian El-Farra A, Holoshitz N, Park K, Albadri A, Blair JA, Jeremias A, Kearney KE, Kobayashi Y, Miner SES, Samuels BA, Shah SM, Taqueti VR, Wei J, Fearon WF, Moses JW, Henry TD, Tremmel JA; Microvascular Network (MVN). Comprehensive Management of ANOCA, Part 2-Program Development, Treatment, and Research Initiatives: JACC State-of-the-Art Review. J Am Coll Cardiol. 2023 Sep 19;82(12):1264-1279. doi: 10.1016/j.jacc.2023.06.044.
- Samuels BA, Shah SM, Widmer RJ, Kobayashi Y, Miner SES, Taqueti VR, Jeremias A, Albadri A, Blair JA, Kearney KE, Wei J, Park K, Barseghian El-Farra A, Holoshitz N, Janaszek KB, Kesarwani M, Lerman A, Prasad M, Quesada O, Reynolds HR, Savage MP, Smilowitz NR, Sutton NR, Sweeny JM, Toleva O, Henry TD, Moses JW, Fearon WF, Tremmel JA; Microvascular Network (MVN). Comprehensive Management of ANOCA, Part 1-Definition, Patient Population, and Diagnosis: JACC State-of-the-Art Review. J Am Coll Cardiol. 2023 Sep 19;82(12):1245-1263. doi: 10.1016/j.jacc.2023.06.043.
- Mila R, Albistur J, Valdez M, Loza G, Torrado J, Bachini J, Murguia S, Acquistapace F, Nobile N, Briano V, Niggemeyer A, Trujillo P, Niell N, Duran A, Alfonso F, Dayan V. "A stratified pathway to stent-free reperfusion: Selecting suitable patients in ST-elevation myocardial infarction". Cardiovasc Revasc Med. 2025 Jun;75:90-97. doi: 10.1016/j.carrev.2024.09.001. Epub 2024 Sep 14.
- Albistur S, Torrado J, Niell N, Mila R. Microvascular dysfunction following deferred stenting strategy in ST-segment elevation myocardial infarction: a case report. Eur Heart J Case Rep. 2023 Nov 14;7(11):ytad564. doi: 10.1093/ehjcr/ytad564. eCollection 2023 Nov.
- Larsen AI, Saeland C, Vegsundvag J, Skadberg MS, Nilsen J, Butt N, Ushakova A, Valborgland T, Munk PS, Isaksen K. Aerobic high-intensity interval exercise training in patients with angina and no obstructive coronary artery disease: feasibility and physiological effects. Eur Heart J Open. 2023 Mar 22;3(2):oead030. doi: 10.1093/ehjopen/oead030. eCollection 2023 Mar.
- Hokimoto S, Kaikita K, Yasuda S, Tsujita K, Ishihara M, Matoba T, Matsuzawa Y, Mitsutake Y, Mitani Y, Murohara T, Noda T, Node K, Noguchi T, Suzuki H, Takahashi J, Tanabe Y, Tanaka A, Tanaka N, Teragawa H, Yasu T, Yoshimura M, Asaumi Y, Godo S, Ikenaga H, Imanaka T, Ishibashi K, Ishii M, Ishihara T, Matsuura Y, Miura H, Nakano Y, Ogawa T, Shiroto T, Soejima H, Takagi R, Tanaka A, Tanaka A, Taruya A, Tsuda E, Wakabayashi K, Yokoi K, Minamino T, Nakagawa Y, Sueda S, Shimokawa H, Ogawa H; Japanese Circulation Society and Japanese Association of Cardiovascular Intervention and Therapeutics and Japanese College of Cardiology Joint Working Group. JCS/CVIT/JCC 2023 Guideline Focused Update on Diagnosis and Treatment of Vasospastic Angina (Coronary Spastic Angina) and Coronary Microvascular Dysfunction. Circ J. 2023 May 25;87(6):879-936. doi: 10.1253/circj.CJ-22-0779. Epub 2023 Apr 6. No abstract available.
研究記録日
主要日程の研究
研究開始 (推定)
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
本研究に関する用語
その他の研究ID番号
- FMV_1_2025_1_186667 (その他の助成金/資金番号：Agencia Nacional de Investigación e Innovación (ANII), Fondo María Viñas)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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