Study to Investigate the Association Between Coronary Flow Reserve and BH4 Levels in Patients With High Cardiovascular Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Coronary Flow Reserve (CFR) Trans Thoracic Doppler Echocardiography
研究概览
简要总结
To determine if there is a relationship between coronary flow reserve (CFR) and platelet/plasma BH2 and BH4 levels in patients with high cardiovascular risk .
详细描述
Primary parameter :
relationship between coronary flow reserve (CFR) and platelet/plasma BH2 and BH4 levels in patients with hypertension and concomitant cardiovascular risk factors.
Secondary parameter:
Levels of cGMP in platelets.
- Study design
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •o men and women (females of childbearing potential must be using highly effective contraceptive precautions such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence or vasectomised partner)
- •Females of childbearing potential or within two years from the menopause must have a negative urine pregnancy test
- •between 40 and 80 years of age
- •documented history of hypertension
- •smokers/non smokers R
- •type 2 diabetes R
- •Moderate to severe kidney disease (GFR >30 and <60 ml/min/1.73m2 (estimated MDRD) R
- •Hypercholesterolemia R
- •Receiving an optimal standard antihypertensive treatment for at least 6 months, stable for at least 15 days
- •All other concomitant treatments stabilized at least for the preceding 15 days
- •Able to give written informed consent
排除标准
- •o Females of childbearing potential not using highly effective contraceptive precautions
- •Patients with obstructive (>50% diameter reduction) CAD on the LAD (based on invasive angiography or coronary CTA) or with evidence of previous myocardial infarction or history of revascularization in the LAD territory.
- •CAD on the RCA or CX with diameter reduction > 50% (based on invasive angiography or coronary CTA) , either native or revascularized (stent)
- •Patients with infectious disease and/or chronic inflammatory diseases
- •Epicardial coronary arteries spasm
- •Patients with severe valve disease and/or significant left ventricular wall motion abnormalities
- •Patients under treatment with non-selective beta blockers including propranolol, nadolol, pindolol, labetalol, penbutolol, sotalol, carvedilol, and timolol.
- •Contraindications to dipyridamole infusion: asthma, bronchospasm, previous < 24 hours ingestion of phylline derivatives (tea, coffee, cola, xanthines and chocolate) sick sinus syndrome, advanced AV block (second and third degree), systolic blood pressure < 90 mmHg, cerebral ischemia, severe sinus bradycardia (heart rate <40/min), use of dipyridamole during the last 24 h, severe atherosclerotic lesions of extracranial artery >75%.
- •Acute treatment or treatment for acute diseases
- •Patients receiving steroidal anti-inflammatory drugs, dietary supplements of folic acid, or antioxidant vitamins.
- •Any condition that may prevent the pt to give informed consent , enter the study or bias the results.
- •Participating into other studies
结局指标
主要结局
Coronary Flow Reserve (CFR) Trans Thoracic Doppler Echocardiography
时间窗: 1 week
Measurement of coronary flow reserve of the left anterior descending coronary artery will be carried out with transthoracic Doppler Echocardiography (TDE) and dipyridamole stress. CFR will be calculated as the ratio between stress and resting flow velocity (cm/sec)
BH2 and BH4 levels (ng/ml) in plasma and platelets
时间窗: 1 week
Blood samples will be withdrawn and subsequently analyzed to assess biopterins BH4 and BH2 ng/mL concentration in plasma and platelets Each will be determined separately from the same sample, by high-performance liquid chromatography followed by serial electrochemical and fluorescent detection.
Relationship between coronary flow reserve (CFR) and platelet/plasma BH2 and BH4 levels.
时间窗: 1 week
Simple regression analysis or logistic regression will be used to test the relationship between CFR and biopterins values in plasma and platelets.
次要结局
- Levels of cGMP in platelets(1 week)
研究者
Prof. Paolo G Camici MD FACC
Professor of Cardiology
IRCCS San Raffaele