Steingart R M, Forman S, Coglianese M, Bittner V, Mueller H, Frishman W, Handberg E, Gambino A, Knatterud G, Conti C R
Winthrop-University Hospital, Mineola, New York, USA.
Clin Cardiol. 1996 Aug;19(8):614-8. doi: 10.1002/clc.4960190807.
Although it is recognized that women have been underrepresented in clinical trials of cardiovascular disease, the reasons for their limited enrollment have not been elucidated.
A prospective tracking system was established in the Asymptomatic Cardiac Ischemia Pilot study (ACIP) to monitor recruitment and identify protocol issues that interfered with the recruitment of women. Patients with stress test evidence for ischemia during the course of routine clinical care were screened for asymptomatic ischemia with an ambulatory electrocardiogram (ECG).
Those with at least one episode of asymptomatic ischemia and angiographic evidence of coronary artery disease suited for revascularization could be randomized. Women comprised only 17% of the 1,820 patients screened for asymptomatic ischemia, and only 14% of the 558 patients randomized. The limited number of women screened for ischemia was largely due to the limited number of women (25% of all patients) found to have test evidence for ischemia or coronary artery disease suited for revascularization during the course of routine clinical care. Once patients were identified as having ischemia on stress test and ambulatory ECG, the major difference in eligibility was the difference in disqualifying angiograms, occurring 21/2 times as frequently in women as in men (p < 0.001).
The percentage of women recruited was lower than the prevalence of ischemic heart disease in the general population because at participating centers (1) women were found to have ischemia less often than men during the course of routine clinical care, and (2) screening tests for ischemia were less predictive of protocol-defined coronary disease in women than in men.
尽管人们认识到女性在心血管疾病临床试验中的参与度一直较低，但其入选人数有限的原因尚未阐明。
在无症状心肌缺血初步研究（ACIP）中建立了一个前瞻性追踪系统，以监测招募情况并识别妨碍女性招募的方案问题。在常规临床护理过程中，对有应激试验证据显示缺血的患者进行动态心电图（ECG）筛查以确定是否存在无症状心肌缺血。
那些至少有一次无症状心肌缺血发作且有适合血运重建的冠状动脉疾病血管造影证据的患者可以被随机分组。在接受无症状心肌缺血筛查的1820名患者中，女性仅占17%；在被随机分组的558名患者中，女性仅占14%。接受缺血筛查的女性人数有限，主要是因为在常规临床护理过程中，发现有缺血试验证据或适合血运重建的冠状动脉疾病的女性人数有限（占所有患者的25%）。一旦患者在应激试验和动态心电图检查中被确定为有缺血，资格认定的主要差异在于不合格血管造影的差异，女性出现不合格血管造影的频率是男性的2.5倍（p<0.001）。
招募的女性比例低于一般人群中缺血性心脏病的患病率，原因在于参与研究的中心：（1）在常规临床护理过程中，发现女性缺血的频率低于男性；（2）女性缺血筛查试验对方案定义的冠状动脉疾病的预测性低于男性。
