REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial - Women

Обзор

This is a research study in women to compare the outcomes of two procedures that restore blood flow to the arteries of the heart. In one procedure the blockages are ballooned and then stented with a small wire mesh tube through a small incision in the wrist or the groin. The other procedure is an open-heart operation in which healthy blood vessels from inside the chest, leg, and/or forearm are used to "bypass" the blockages (like a detour). Outcomes will be measured by comparing survival and improvement in quality-of-life.

Подробное описание

The RECHARGE: Women Trial is a multicenter, 1:1 randomized, open-label superiority trial.

Patients meeting the eligibility criteria for whom there is equipoise for revascularization with CABG and PCI, as determined by the local Heart Team, will be included. Participants will be followed for 5-10 years. Telephone follow-up will be conducted by the a central follow-up coordinating center at 30 days, 3 months, 6 months, and thereafter every 6 months through 36 months post-randomization. After 36 months, follow-up will be performed every year (48, 60, 72, 84, 96, 108, 120 months). A repeat transthoracic echocardiogram and blood draw for serum creatinine, hemoglobin and lipids should be performed at 1 year, as per standard of care, at either an out-patient facility or in a hospital.

Вмешательства

• Процедура Coronary artery bypass grafting (CABG)
  Coronary artery bypass grafting (CABG), also called heart bypass surgery, is a medical procedure to improve blood flow to the heart.
• Процедура Percutaneous coronary intervention (PCI)
  Percutaneous coronary intervention (PCI) is a non-surgical procedure used to treat the blockages in a coronary artery; it opens up narrowed or blocked sections of the artery, restoring blood flow to the heart

Первичные конечные точки

• Hierarchical composite of all-cause death and time-averaged change from baseline in generic quality of life using the SF-12v2 [Срок оценки: 5 years]

Вторичные конечные точки (1)

• Time averaged change from baseline in disease-specific quality of life using the SAQ-OS [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Female sex
• Patient is at least 18 years old.
• Multivessel or left main CAD is present for which revascularization is intended and for which there is equipoise between CABG and PCI according to local Heart Team assessment.
• Ability to provide written informed consent and comply with all follow-up procedures, including QOL questionnaires.

Критерии исключения

• ST-segment elevation MI within 3 days
• Cardiogenic shock
• Prior PCI within 1 year or any prior CABG anytime
• Planned hybrid revascularization (PCI after CABG or CABG after PCI)
• Planned single vessel revascularization (other than isolated left main disease)
• Need for any cardiac surgical or interventional procedure other than coronary revascularization at the present time or anticipated within 3 years
• Pregnancy (women of child-bearing potential must have a negative pregnancy test within 1 week before randomization) or intent to become pregnant within 1 year after randomization
• Unable to tolerate, obtain or comply with dual antiplatelet therapy for at least 3 months if presentation with stable CAD or 6 months if presentation with a troponin-positive acute coronary syndrome
• Current participation in another investigational drug or device study that has not reached its primary endpoint
• Life-expectancy less than 3 years due to concomitant non-cardiac conditions
• Any condition(s) are present that are likely to interfere with the study protocol procedures including medication adherence and follow-up through 10 years (e.g. mental disability, substance abuse, anticipated international relocation, etc.)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 18 центров

• Adventist Health Glendale — Glendale
• Emory University — Atlanta
• Ascension St. Vincent Cardiovascular Research Institute — Carmel
• Baptist Health Lexington — Lexington
• Baptist Health Louisville — Louisville
• Massachusetts General Hospital — Boston
• Englewood Hospital — Englewood
• NewYork-Presbyterian Hospital - Queens — Flushing
• … и ещё 10 центров

Публикации

• Gaudino M, Stone GW, Puskas J, Krieger K, Redfors B, Bagiella E, Gelijns A, Bhatt DL, Sandner S, Barman N, Bozinovski J, Gee P, Haider A, Hafiz AM, Jolly SS, Li D, Mack C, Madani MM, Mahmud E, Pineda AM, Masoudi FA, Mazzaferri E, Monroe R, Nicholson W, Pocock SJ, Sachdeva R, Yong C, Zwischenberger BA, Yancy C, Creber RM, Spertus J. Lessons learned from the feasibility phase of the REvascularizatio PMID 42323001
• Nino de Rivera S, Suero-Tejeda N, Monroe R, Tang M, Eslami S, Sallam A, Gee PO, Redfors B, Yancy C, Gaudino M, Stone GW, Spertus J, Masterson Creber R. Patient Perspectives in Cardiovascular Research: A Qualitative Study of Barriers, Trust, and Strategies for Inclusive Clinical Trials. Circ Popul Health Outcomes. 2026 Jun 12:e012189. doi: 10.1161/CIRCOUTCOMES.125.012189. Online ahead of print. PMID 42283075

Идентификаторы

NCT: NCT06399692 · 23-11026800 - 1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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