Anticoagulation Therapy in the Very Old (ATIVO)
ATIVO Study - Anticoagulation Therapy in the Very Old
調査の概要
詳細な説明
This is a prospective registry study with data being collected continuously for 24 months.
Patients who have electrocardiographically confirmed atrial fibrillation, are being followed by the Pen Bay Medical Center Anticoagulation Services and are at least 90 years old will be recruited into the study. A matched cohort of patients between the ages of 80 and 89 and another matched cohort of patients between the ages of 70 and 79 will also be recruited into the study for comparison.
Data related to adverse events, concomitant medications, living arrangements, mobility and alcohol use will be collected every 6 months. In addition the CHA2DS2-VASc (score for atrial fibrillation stroke risk), HAS - BLED (major bleeding risk score for patients on anticoagulation), frailty and Mini Cog scores will be recalculated at each visit.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Maine
-
Rockport、Maine、アメリカ、04856
- Penobscot Bay Medical Center
-
-
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:
- 70 years of age or older
- electrocardiographically confirmed atrial fibrillation
- anticipated regular follow up with patient by Penobscot Bay Medical Center (PBMC) Anticoagulation Services
- Subject or legally authorized representative must be willing to provide informed consent
Exclusion Criteria:
- Patients not being followed by the PBMC Anticoagulation Services
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
- 観測モデル：コホート
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Aged 90 and older
Subjects 90 years and older with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
|
Patients on warfarin for atrial fibrillation
他の名前：
|
|
Aged 80-89
Subjects aged 80-89 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
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Patients on warfarin for atrial fibrillation
他の名前：
|
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Aged 70-79
Subjects aged 70-79 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
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Patients on warfarin for atrial fibrillation
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 |
|---|---|---|
|
Number of Patients Experiencing Stroke
時間枠：24 months
|
Every 6 months the medical record was reviewed for evidence of stroke of any cause.
|
24 months
|
|
Number of Patients Experiencing a Major Bleeding Event
時間枠：24 months
|
defined as one of the following: fatal bleeding, symptomatic bleeding in a critical area or organ or bleeding causing a fall in hemoglobin of 2 g/dl or more or leading to a transfusion of 2 or more units of whole blood or red cells
|
24 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Patients Experiencing a Traumatic Subdural Hemorrhage
時間枠：24 months
|
Number of subjects who experienced a traumatic subdural hemorrhage in each age group
|
24 months
|
|
Number of Patients Experiencing a Traumatic Intracerebral Hemorrhage
時間枠：24 months
|
Number of subjects who experienced a traumatic intracerebral hemorrhage in each age group
|
24 months
|
|
Number of Hospitalizations Patients Experienced
時間枠：24 months
|
Every 6 months the medical record was reviewed for any hospitalizations experienced by the subject within our healthcare system.
|
24 months
|
|
Number of Patients Experiencing Cardiovascular Death
時間枠：24 months
|
Every 6 months the medical record was reviewed.
All deaths were researched for cause and noted if the cause was related to the cardiovascular system.
|
24 months
|
|
Number of Patients Experiencing Death Related to Anticoagulation
時間枠：24 months
|
All deaths were reviewed in the medical record to determine the cause and if it was related in any way to the use of anticoagulation therapy.
|
24 months
|
|
Mean Time in Therapeutic Range at End of Study Participation
時間枠：up to 24 months
|
International Normalized Ratio (INR) time in therapeutic range at the end of the individual's study participation.
|
up to 24 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Robert W. Stein, MD、MaineHealth
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。