Cardiac Autonomic Function in Women With Microvascular Coronary Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Cardiovascular Reactivity (CVR)
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 impacts women. There are an estimated 2-3 million women in the US with MCD and about 100,000 new cases annually. Autonomic nervous system (ANS) is part of the central nervous system to help people adapt to changes in their environment. It controls what are normally involuntary activities, such as heart rate, respiration (breathing), body temperature, blood pressure, and urinary function. However, there is a limited understanding of the role of ANS in MCD. This research is proposed to investigate cardiovascular reactivity to mental stress and the cardiac (heart) nervous system in women with MCD using mental stress testing, peripheral vascular testing, advanced cardiac imaging and cardiac autonomic function testing. 100 participants will be recruited in the next five years.
详细描述
There are three groups in this study: 40 MCD subjects with abnormal coronary reactivity testing (CRT), 20 CSX subjects with symptoms and nomral stress testing, and 40 normal controls. Normal controls will complete two study visits while MCD subjects may have up to three study visits.
Recruiting participants from Protocol 14906:
To date, no participants from Protocol 14906 have completed the study yet. All the participants who are currently enrolled in 14906 will be approached by the investigator at their next study visits. Prospectively new participants will be approached while they are consented for 14906.
Recruiting participants from Protocol 11753:
Participants who are currently enrolled in Protocol 11753 will be approached at their next study visits. Prospectively new participants will be approached while they are consented for 11753. Research staff may also identify past patients who have completed 11753 and fulfill the requirements for healthy individuals.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for Protocol 14906:
- •Women with symptomatic angina or angina equivalent;
- •Age > 18 yrs old;
- •No obstructive CAD at coronary angiography (performed within the previous 24 months);
- •Competent to give informed consent.
- •Inclusion criteria for Protocol 11753:
- •Women without signs and symptoms of myocardial ischemia (chest pain, abnormal stress testing, abnormal noninvasive testing);
- •No cardiac risk factors by Framingham/NCEP criteria;
- •Age (35-65) matched to the WISE MCD population;
- •A normal maximal exercise stress test.
排除标准
- •Exclusion criteria for Protocol 14906:
- •Obstructive CAD greater than or equal to 50% luminal diameter stenosis in greater than or equal to 1 epicardial coronary artery;
- •Acute coronary syndrome (defined by the ACC/AHA criteria, Braunwald 2000);
- •Primary valvular heart disease clearly indicating the need for valve repair or replacement;
- •Patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support;
- •Prior or planned percutaneous coronary intervention or CABG;
- •Acute MI;
- •Prior non-cardiac illness with an estimated life expectancy < 4 years;
- •Unable to give informed consent;
- •Chest pain with a non-ischemic etiology (e.g.,pericarditis, pneumonia, esophageal spasm);
- •Contraindications to CMRI (e.g., AICD, pacemaker, untreatable claustrophobia or known angio-edema);
- •Women with intermediate coronary stenoses (> 20% but < 50% luminal diameter stenosis assessed visually at the time of angiography) will undergo clinically indicated IVUS testing based on the judgement of the operator; Those determined to have flow-obstructing stenosis will be excluded from the overall study;
- •Participation in a research study that conflicts with the current WISE study.
- •Women with coronary stenosis ≥50% in any epicardial coronary artery, assessed visually at the time of angiography, will not be included in the CRT subgroup.
- •Women who are pregnant.
- •Exclusion criteria for Protocol 11753:
- •Contraindications to CMR testing (metal devices in chest, claustrophobia, known angioedema);
- •Contraindication to Adenosine including asthma, heart block (second and third degree) and sinus node disease, significant COPD/asthma, or systemic hypotension (<90mmHg);
- •Contraindication to Dobutamine including severe systemic hypertension (≥ 220/120 mmHg), unstable angina, significant aortic valve stenosis, complex cardiac arrhythmia including uncontrolled atrial fibrillation, hypertrophic obstructive cardiomyopathy, myocarditis, endocarditis, pericarditis, or uncontrolled congestive heart failure;
- •Contraindication to Gadolinium (renal impairment);
- •Any renal disease;
- •Pregnant and lactating women;
- •Inability to perform exercise, e.g. orthopedic limitations.
结局指标
主要结局
Cardiovascular Reactivity (CVR)
时间窗: 24 hours
Cardiovascular Reactivity (CVR)
次要结局
未报告次要终点
研究者
Noel Bairey Merz
Director
Cedars-Sinai Medical Center