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
調査の概要
詳細な説明
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)
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Bergamo、イタリア、24127
- ASST Papa Giovanni XXIII
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Milan、イタリア、20132
- IRCCS Ospedale San Raffaele
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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健康管理
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Echo stress dipyridamole
他の名前:
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高血圧患者
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Echo stress dipyridamole
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
BH2 and BH4 levels (ng/ml) in plasma and platelets
時間枠: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
時間枠: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.
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Levels of cGMP in platelets
時間枠: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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Echo stress dipyridamoleの臨床試験
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University College, LondonUniversity of Roehampton完了うつ | ストレス、心理 | 不安
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Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and Development; Brain & Behavior Research... と他の協力者募集
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Hong Kong Baptist UniversityStockholm University; Research Grants Council, Hong Kong完了
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Oregon Health and Science UniversityUniversity of Colorado, Denver完了
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University of California, San FranciscoUnited States Department of Defense; San Francisco Veterans Affairs Medical Center完了
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University of PittsburghNational Cancer Institute (NCI)招待による登録
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University of North Carolina, Chapel HillBristol-Myers Squibb; Duke University; Wake Forest University招待による登録