Optical Coherence Tomography Assessment of Gender diVersity In Primary Angioplasty: The OCTAVIA Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 主要终点
- percentage of ruptured or eroded plaques at infarct related lesion as assessed by OCT before PCI
研究概览
简要总结
Recent studies suggest important gender differences in the pathophysiology and prognosis of ST-segment elevation myocardial infarction (STEMI). This is the first prospective controlled study to assess gender differences in the mechanism of plaque rupture/erosion and thrombus formation in patients presenting with STEMI treated with primary angioplasty. Gender-related mechanisms of plaque rupture or erosion will be investigated using a combination of Quantitative Coronary Angiography (QCA), high resolution Optical Coherence Tomography (OCT) of the culprit vessel and histopathology analyses of thrombus aspirates of the infarct related lesion, performed by independent core laboratories, blinded to group (male or female) and clinical variables.
In OCTAVIA; enrollment in a 1:1 ratio according to gender group will be ensured by a computer-assisted matching algorithm for gender and age (< 50, 51-70, and > 70 years). Matching has the purpose to enable enrollment of an even number of male and female patients in balanced age groups. This type of dynamic algorithm is appropriate when the composition of the referral population is not known in advance.
The sample size for the OCTAVIA study was calculated on the basis of per patient stent strut coverage (a continuous variable with right skewed distribution) with mean of 97.0% and standard deviation of 4.0% in men, versus mean of 95.0% and standard deviation of 4.0% in women, following XIENCE PRIME™ Everolimus Eluting Coronary Stent System implantation. Thus, aiming for a 5% 2-tailed superiority alpha, an 80% power, and assuming a 1:1 enrollment according to gender, a total of 64 patients per group should be enrolled. Anticipating a 10% dropout rate due to patients lost to follow-up and inadequate imaging (included major side branch sections), the total enrollment is set at 70 patients per group (total population of 140 subjects).
详细描述
A suboptimal degree of attention has focused on the detection and management of coronary artery disease (CAD) in women until recently. Although many women do not perceive heart disease as a significant health risk, CAD is the leading cause of mortality in women in most developed nations, with mortality primarily driven by acute ST-elevation myocardial infarction (STEMI) and cardiogenic shock (American Heart Association 2005 Heart Disease and Stroke Statistics).
In recent years, literature articles regarding various aspects of heart disease in women significantly increased. These reports have highlighted important sex differences in the pathophysiology, presentation, and treatment of ischemic heart disease and have denounced pervasive sex-related disparities in referral and treatment for heart disease as a major reason for outcome differences between the sexes. Such activities have been useful in driving attention to heart disease in women, an area largely ignored by the scientific community and the public just 20 years ago.
However, we must recognize that to date, limited data substantiate many of these statements; such recognition is important to guide future research efforts. A careful look at recently published literature reveals only modest advancements toward clarifying gender-based differences in the pathophysiology of ischemic heart disease and gender-based differences in outcome. At the same time, key questions concerning strategies for prevention and treatment of heart disease in women remain unanswered, and cardiovascular clinical trials continue to include fewer women than men.
A fundamental question is whether the mechanisms underlying ischemic heart disease in women differ from those in men. This is an important question because if pathophysiology differs in women, such differences can inform strategies for prevention, detection, and treatment that would be most effective for women.
A number of indicators point to a different mechanism in man and women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute Myocardial MI with ST segment Elevation, within 6 hours from symptoms onset
- •Native coronary artery disease (no prior stent implant, no prior brachytherapy)
- •Signed patient informed consent
排除标准
- •Patients with left main disease
- •infarct lesions in bypass grafts
- •cardiogenic shock
- •renal failure
- •recent major bleeding
- •allergy to aspirin or clopidogrel
- •on anticoagulant therapy
- •no suitable anatomy for OCT (extreme tortuousity, very distal culprit lesion, and large infarct vessel > 4 mm in diameter)
结局指标
主要结局
percentage of ruptured or eroded plaques at infarct related lesion as assessed by OCT before PCI
时间窗: within 6 hours from symptoms onset
To assess gender differences in the percentage of ruptured or eroded plaques at infarct related lesion as assessed by OCT before PCI.
次要结局
- Presence and type of thrombus at culprit site(within 6 hours from symptoms onset)
- Minimal Fibrous Cap Thickness (µm) at infarct-related lesion.(within 6 hours from symptoms onset)
- Number of Thin Cat Fibroatheroma (TCFA) (<65 µM) in the scanned segment.(within 6 hours from symptoms onset)
- percent of incompletely apposed-uncovered struts(9 months)
- percent net volume obstruction(9 months)
- percent abnormal intraluminal tissue(9 months)
- percent of covered stent struts by OCT(9 months)
研究者
GGuagliumi
MD
A.O. Ospedale Papa Giovanni XXIII