Evaluation of Patients With Angina in the Absence of Obstructive Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Number of participants with major adverse cardiovascular events (MACE)
研究概览
简要总结
Patients with angina and non-obstructive CAD are common within clinical practice, but remain a challenge with regard to diagnosis and treatment. When these patients undergo a comprehensive evaluation at the time of invasive coronary angiography, occult coronary abnormalities are frequently found. We hope to learn the overall prevalence and presentation of these occult coronary abnormalities and its long term outcome in this patient population.
详细描述
This is a prospective registry of patients with chest pain, chest discomfort, breathlessness who do not have a blockage in their heart artery. This condition is known as angina/ischemia and non-obstructive coronary arteries (ANOCA/INOCA). The purpose of this registry is to help us understand the prevalence, causes of these conditions, identify effective diagnostic strategy, and long term outcome in this patient population.
Patients will undergo comprehensive invasive evaluation including coronary angiography, intravascular imaging, and physiologic measurements as a standard of care. Details regarding the participant's angiogram, endothelial function testing, microvascular testing, intravascular ultrasound, and myocardial bridge testing, if performed, will be entered into a research database.
Participants may be contacted by email or phone periodically for follow-up information, such as surveys, an update on medical history, and/or a check on their medical status or symptoms. We anticipate gathering these data at 6 months, 1 year, 3 years, 5 years, and 10 years, and every 5 years thereafter following their enrollment.
The overall objective of this registry study is to identify specific endotypes of ANOCA by invasive evaluation and study long term outcome.
Specific goals include:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patient referred for elective coronary angiography because of a reasonable clinical suspicion of coronary ischemia.
- •Presence of angina or an anginal equivalent (including chest, back, shoulder, arm, neck, jaw discomfort, or shortness of breath brought on by physical exertion, emotional stress, or certain times of day/month).
排除标准
- •Asymptomatic (such as a pre-op cath)
- •Status-post heart transplant
- •Renal insufficiency (creatinine >1.5)
- •Presence of an acute coronary syndrome (STEMI or NSTEMI), Tako-tsubo, an abnormal ejection fraction (EF<55%), cardiogenic shock, or recent VT/VF
- •Presence of another likely explanation of chest pain, such as pulmonary hypertension or aortic stenosis
- •History of adverse reaction to any of the medications being used (acetylcholine, nitroglycerin, adenosine, or heparin)
- •Currently taking vasoactive medication (such as nitroglycerin)
- •Inability to provide an informed consent, including an inability to speak, read, or understand English, Spanish, Chinese, Farsi, Japanese, Korean, Russian, or Vietnamese
- •A hearing impairment that won't allow for a typical verbal conversation or a visual impairment that won't allow for reading of the written consent
- •Participation in another study (with the exception of the Stanford Gene-PAD study)
- •A potentially vulnerable subject (including minors, pregnant women, economically and educationally disadvantaged, decisionally impaired, and homeless people)
结局指标
主要结局
Number of participants with major adverse cardiovascular events (MACE)
时间窗: 15 years
MACE - death, heart attack, revascularization, stroke
Sex Differences in Endothelial Dysfunction, Microvascular Dysfunction, and Diffuse Plaque
时间窗: Day of procedure (study day one)
This outcome is to measure the prevalence of angina and non-obstructive coronary arteries (ANOCA) endotypes
次要结局
- Number of patients with cardiovascular rehospitalization(15 years)
- Change in Seattle angina questionnaire score(Baseline, 6 months, 1 year, 3 year, every 5 years thereafter)
研究者
Jennifer A Tremmel, MD, MS
Associate Professor
Stanford University