BRAVO: Biomarker Risk Assessment in Vulnerable Outpatients (BRAVO)
The investigators hypothesize that among people with lower extremity peripheral artery disease (PAD), biomarker levels are higher during time periods immediately preceding an acute coronary event compared to time periods not immediately preceding an acute coronary event. Biomarkers the investigators will study are CRP, SAA, and D-dimer. Biomarkers will be measured at baseline and every two months during follow-up.
The primary aims of this study are as follows. Specific Aim #1. Among participants with PAD who experience an acute coronary event during follow-up, the investigators will determine whether biomarker levels measured immediately prior to the coronary event are higher than levels that do not immediately precede coronary events. Specific Aim #2, Part 1. The investigators will determine whether participants who experience a coronary event (cases) have higher biomarker levels at the visit immediately prior to the event than participants who have not experienced a coronary event (controls) at the time of the case event. Specific Aim #2, Part 2. The investigators will determine whether participants who experience a coronary event (cases) have a greater increase in biomarkers during the time period leading up to the event compared to participants who have not experienced a coronary event (controls).
To achieve these aims, the investigators will enroll up to 650 participants with PAD and follow them prospectively, measuring blood samples every two months, and ascertaining the presence of acute coronary events every two months.
調査の概要
状態
条件
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Illinois
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Chicago、Illinois、アメリカ、60637
- University of Chicago Medical Center
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Chicago、Illinois、アメリカ、60611
- Northwestern University Feinberg School of Medicine
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Chicago、Illinois、アメリカ、60612
- Rush Medical Center
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Chicago、Illinois、アメリカ、60608
- Mt. Sinai Medical Center
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Chicago、Illinois、アメリカ、60612
- Jesse Brown Veterans Administration Medical Center
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Chicago、Illinois、アメリカ、60657
- St. Joseph's Hospital
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
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:
- Peripheral arterial disease defined as an ABI less than or equal to 0.90 in either leg
We will also include PAD patients with an ABI > 0.90 who meet any of the following criteria:
- History of documented lower extremity revascularization. A written report from the medical record will be required as documentation
- An angiogram demonstrating >50% stenosis in one or more lower extremity arteries. Again, a written report will be required to document this. Participants with an angiogram noting moderate or greater stenosis will also be considered eligible, when a specific amount of stenosis is not denoted
- A report from the non-invasive vascular laboratory demonstrating a toe brachial pressure less than 0.60. Other criteria (i.e. PVR data) from the non-invasive vascular laboratory will not be considered sufficient for inclusion
Exclusion Criteria:
- Treatment for cancer other than non-melanoma skin cancer during the previous 2 years. (However, persons treated for non-invasive breast cancer or prostate cancer during the previous year will be potentially eligible if their physician indicates that their life expectancy is > 24 months, since non-invasive breast and prostate cancer often have an excellent prognosis)
- Unintentional weight loss of > 7.5 pounds in the last six months;
- Mini-Mental Status Exam (MMSE) score < 23 out of 30 or other history of cognitive impairment
- Communication difficulty due to language barriers
- Refusal to have regular blood draws or inability to obtain a blood sample at baseline
- Coronary or cerebrovascular event during the previous six months (these persons may become eligible at a later date)
- History of inflammatory arthritis (rheumatoid arthritis, lupus erythematosis, or polymyalgia rheumatic, gout), however participants with gouty arthritis will be eligible if the last episode was more than three months ago
- Residence more than 40 miles away from the medical center and unwillingness to travel to the medical center for every two month blood collection
- Unable to return for follow up testing for > a consecutive six month period in the next two years
- Heart transplant surgery
- Major surgery (one that required general anesthesia) within the past 3 months These persons may become eligible at a later date
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 |
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PAD Participants
PAD participants from among consecutive patients with PAD identified from Chicago area non-invasive vascular laboratories
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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 |
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fatal and non-fatal coronary events
時間枠:Every two months for up to three and a half years
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Our primary outcome is fatal and non-fatal coronary events.
Non-fatal coronary events will be defined as acute myocardial infarction (MI), hospitalizations for unstable angina, and new ECG findings consistent with MI
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Every two months for up to three and a half years
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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
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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。
末梢動脈疾患の臨床試験
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Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ