Microcirculatory Dysfunction in Stable Coronary Artery Disease: Relationship With Patient-focused Outcomes, Cerebral Small Vessel Disease and Depression.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Prevalence of Cerebral Small Vessel Disease (CSVD).
研究概览
简要总结
This is a prospective cohort blinded study with the aim to investigate the prevalence and clinical impact of coronary microcirculatory dysfunction (CMD) in patients with ischemic heart disease, and its association with cerebral small vessel disease (CSVD) and depressive disorders. In addition, CMD and CSVD linkage to systemic inflammation and endothelial function will also be investigated.
详细描述
The treatment of stable CAD is largely based on a paradigm that gives epicardial coronary stenoses a central role in the generation of myocardial ischaemia. However, coronary microcirculatory dysfunction (CMD) is a major and frequently ignored cause of ischaemia that, according to retrospective studies, influences the outcomes of patients with CAD. In addition, patients with CMD may not experience symptomatic relief with myocardial revascularization or pharmacological treatment. This constitutes one of the causes of persistent angina despite successful revascularization, causing not only an impairment of the quality of life and higher consumption of healthcare resources, but potentially affective disorders like depression, which has been found to be associated with CAD and with prognosis.
It also remains largely unknown whether CMD in stable CAD is organ-specific only or rather indicative of involvement of other vital organs. While this seems to be the case in the kidney and the retina, the relationship between CMD in the heart and the brain has not been studied. Beyond classical cardiovascular risk factors linked to the development of ischemic heart disease, systemic endothelial dysfunction could constitute a link between microcirculatory involvement in both organs: the heart and the brain. Additionally, the relation between chronic inflammatory status and microvascular disease in both the heart and the brain is not known.
The principal hypotheses and sub-hypotheses are as follows:
Principal hypotheses: 1. Patients with CMD have worse prognosis compared to those ones with normal coronary microcirculation. 2. Patients with CMD have a higher prevalence of CSVD. 3. Chronic systemic inflammation status is an independent predictor of CMD and CSVD.
Sub-hypotheses: 1. The presence of CMD is associated to recurrent/persistent angina. 2. The presence of CMD is associated to higher prevalence of depressive disorders. 3. CMD and CSVD are associated to systemic endothelial dysfunction.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Informed Consent available.
- •Age ≥ 18 years.
- •Stable coronary lesions.
- •Indication to FFR: ≥ 1 intermediate coronary lesion (40-80% diameter stenosis) in a principal/secondary vessel with ≥ 2 mm reference diameter.
排除标准
- •Previous myocardial infarction in the territory of distribution of the target vessel.
- •Coronary Left Main severe stenosis.
- •Aortic valve stenosis (moderate or severe) .
- •Severe left ventricle hypertrophy.
- •Left ventricle moderate systolic dysfunction (EF < 35%).
- •Contraindications to adenosine.
- •Previous CABG with permeable grafts.
- •Contraindication to stent implantation.
- •Severe anemia.
- •Coagulopathies or chronic anticoagulation.
- •Platelets < 75000 o > 700.
- •Previous stroke or intracranial hemorrhage.
- •Contraindication to MRI.
- •Chronic Renal Failure contraindicating gadolinium infusion during MRI: eGFR < 60 ml/min), hemodialysis, previous renal transplantation.
- •Pacemaker/ Implantable Cardioverter Device with contraindication to MRI.
- •Planned cardiac surgery.
- •Life expectancy < 2 years.
结局指标
主要结局
Prevalence of Cerebral Small Vessel Disease (CSVD).
时间窗: 1 year
Determined by Cerebral MRI, transcranial Doppler Ultrasound and clinical assessment.
Incidence of Major Cardiovascular Events (MACE): all-cause of death, myocardial infarction and any type of coronary revascularization
时间窗: 1 year
Clinical assessment.
次要结局
- Assessment of angina status by Seattle Angina Questionnaire (SAQ)(1 year)
- Prevalence of depressive and anxiety disorders, determined by clinical assessment and dedicated questionnaires.(1 year)
- Prevalence of systemic inflammation status, determined by laboratory blood tests.(1 year)
- Peripheral endothelial dysfunction, assessed by EndoPat.(1 year)
研究者
Javier Escaned
Principal Investigator
Instituto de Salud Carlos III