DEVELOPMENT OF A NOVEL STRESS TESTING PROTOCOL TO DEFINE THE RELATIONSHIP BETWEEN CORONARY MICROVASCULAR DYSFUNCTION AND DIASTOLOGY IN WOMEN WITH ANGINA BUT NO EVIDENCE OF OBSTRUCTIVE CORONARY ARTERY DISEASE
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Diastolic function by MRI
研究概览
简要总结
Microvascular coronary dysfunction (MCD) (abnormities in small blood vessels/arteries in heart) with symptoms of persistent chest pain, primarily impacts women. There are an estimated 2-3 million women in the US with MCD and about 100,000 new cases annually. Recent data from our research group suggests that coronary microvascular disease impairs the way the heart relaxes. This pilot study will attempt to exacerbate this phenotype in an effort to better understand the pathophysiology of the disease. The investigators will recruit 30 volunteers total (10 healthy calibration subjects, 10 women with microvascular disease, and 10 age-match women for the group with microvascular disease). Subjects will undergo a series of "stress" maneuvers in conjunction with advanced cardiac magnetic resonance imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Fully understanding and willing to undergo study procedures
- •Male or Female greater than or equal to 18 years of age
- •Understanding and willing to sign consent form.
排除标准
- •History of cardiovascular, pulmonary, or neurological disease
- •Hypertension (sitting blood pressure >140/90 mmHg, with measurements recorded on at least 2 occasions)
- •Unable to give informed consent;
- •Contra-indication to CMRI testing, including claustrophobia and metallic implants
- •Adherence or retention issues;
- •Women who are pregnant.
- •Allergy to animal dander.
研究组 & 干预措施
Women w/microvascular disease
10 women with microvascular disease
干预措施: Handgrip (Other)
Women w/microvascular disease
10 women with microvascular disease
干预措施: Altitude simulation (Other)
Women w/microvascular disease
10 women with microvascular disease
干预措施: Leg exercise (Other)
Normal controls
10 age-matched women with no evidence of microvascular disease
干预措施: Handgrip (Other)
Normal controls
10 age-matched women with no evidence of microvascular disease
干预措施: Altitude simulation (Other)
Normal controls
10 age-matched women with no evidence of microvascular disease
干预措施: Leg exercise (Other)
calibration
10 healthy individuals who will help to synchronize our imaging and stress testing maneuvers.
干预措施: Handgrip (Other)
calibration
10 healthy individuals who will help to synchronize our imaging and stress testing maneuvers.
干预措施: Altitude simulation (Other)
calibration
10 healthy individuals who will help to synchronize our imaging and stress testing maneuvers.
干预措施: Leg exercise (Other)
结局指标
主要结局
Diastolic function by MRI
时间窗: 24 hours
次要结局
未报告次要终点
研究者
Noel Bairey Merz
Director
Cedars-Sinai Medical Center