Association Between Coronary Flow Reserve and BH4 Levels in High CV Risk
Study to Investigate the Association Between Coronary Flow Reserve and BH4 Levels in Patients With High Cardiovascular Risk
研究概览
详细说明
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.
4. Study design
Three parallel groups of patients (n=15 per group):
- Group 1 with normal coronary flow reserve (CFR ≥2.5)
Group 2 with reduced coronary flow reserve (CFR≤2.0)
o Group 3 control subjects (without a high risk profile according to ESC score chart http://www.heartscore.org. ) matched for age (between 40 and 80 years of age)
- and gender. 1/3 enrolled patients must be diabetic (Type2 diabetes)
研究类型
注册 (实际的)
联系人和位置
学习地点
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Bergamo、意大利、24127
- ASST Papa Giovanni XXIII
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Milan、意大利、20132
- IRCCS Ospedale San Raffaele
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
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
Exclusion Criteria:
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
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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健康控制
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Echo stress dipyridamole
其他名称:
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高血压患者
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Echo stress dipyridamole
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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BH2 and BH4 levels (ng/ml) in plasma and platelets
大体时间:1 week
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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.
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1 week
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Coronary Flow Reserve (CFR) Trans Thoracic Doppler Echocardiography
大体时间:1 week
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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)
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1 week
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Relationship between coronary flow reserve (CFR) and platelet/plasma BH2 and BH4 levels.
大体时间:1 week
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Simple regression analysis or logistic regression will be used to test the relationship between CFR and biopterins values in plasma and platelets.
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1 week
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Levels of cGMP in platelets
大体时间:1 week
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Comparison of levels of cGMP in platelets among normals, patients with normal CFR and patients with reduced CFR
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1 week
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Echo stress dipyridamole的临床试验
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University of North Carolina, Chapel HillBristol-Myers Squibb; Duke University; Wake Forest University邀请报名
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Oregon Health and Science UniversityUniversity of Colorado, Denver完全的
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Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and Development; Brain & Behavior Research... 和其他合作者招聘中