PACE Cognition Proof-of-Concept Study
Impact of Physiologic Pacemaker Programming on Cognitive Function and Health Status in Patients With Symptomatic Bradycardia
This proof-of-concept study will evaluate whether physiologic pacemaker programming improves cognitive function and health status in patients with symptomatic bradycardia who require permanent pacemaker implantation.
Participants will be randomized to either standard pacemaker programming at 60 beats per minute or individualized physiologic rate pacing between 60 and 90 beats per minute using the myPACE algorithm. Cognitive function and health status will be assessed before pacemaker implantation and again at the routine 3-month pacemaker clinic visit.
The primary outcome is change in Montreal Cognitive Assessment total score. The secondary outcome is change in SF-36 mental component summary score.
調査の概要
状態
詳細な説明
Cardiac pacing may improve cognition by restoring physiologic heart rates, enhancing cerebral perfusion, and improving overall cardiovascular function in patients with symptomatic bradycardia who require permanent pacemaker implantation. In current clinical practice, the lower pacing rate is commonly programmed to 60 beats per minute, which is below the normal resting heart rate in many adults.
PACE Cognition is a proof-of-concept study evaluating the impact of physiologic pacemaker programming on cognitive function and health status. Patients requiring permanent pacemaker implantation for bradycardia will be screened before device implantation. Interested and eligible patients will provide written informed consent before any study-specific procedures are performed.
Baseline cognitive and health-status assessments will be completed before pacemaker implantation. Cognitive function will be assessed using the Montreal Cognitive Assessment, a brief standardized screening instrument that evaluates multiple cognitive domains, including memory, attention, language, visuospatial ability, executive function, and orientation. Health status and functional well-being will be assessed using the SF-36 questionnaire, including the mental component summary score.
Participants will be randomized to either standard pacing at 60 beats per minute or individualized physiologic rate pacing between 60 and 90 beats per minute using the myPACE algorithm. Follow-up Montreal Cognitive Assessment and SF-36 assessments will be repeated at the routine 3-month pacemaker clinic visit to evaluate changes in cognitive performance and health status between the pacing strategies.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Markus Meyer, MD
- 電話番号：802-922-0656
- メール：markusmeyermd@gmail.com
研究連絡先のバックアップ
- 名前：Samantha Wansing
- メール：hoppx054@umn.edu
研究場所
-
-
Minnesota
-
Minneapolis、Minnesota、アメリカ、55455
- University of Minnesota Medical Center
-
コンタクト：
- Markus Meyer, MD
- 電話番号：612-625-9538
- メール：meye3249@umn.edu
-
主任研究者：
- Markus Meyer, MD
-
Minneapolis、Minnesota、アメリカ、55455
- M Health Fairview Clinics and Surgery Center
-
コンタクト：
- Samantha Wansing
- メール：hoppx054@umn.edu
-
コンタクト：
- Markus Meyer, MD
- 電話番号：612-625-9538
- メール：meye3249@umn.edu
-
主任研究者：
- Markus Meyer, MD
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Patient requiring a pacemaker for bradycardia
Exclusion Criteria:
- Vulnerable adult unable to give consent
- Unable to answer questionnaire
- Children
- Pregnant women/persons
- Prisoners
- Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent
- Non-English speakers
- Individuals unable to read
- Employees or students of the researcher
- Active members of the military or DoD personnel
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Standard Pacemaker Programming
Participants randomized to this arm will receive standard pacemaker programming with a lower pacing rate of 60 beats per minute after permanent pacemaker implantation for bradycardia.
|
Standard pacemaker programming with a lower pacing rate of 60 beats per minute will be used after permanent pacemaker implantation.
|
|
実験的：Physiologic Pacemaker Programming
Participants randomized to this arm will receive individualized physiologic pacemaker programming between 60 and 90 beats per minute using the myPACE algorithm after permanent pacemaker implantation for bradycardia.
|
Individualized physiologic pacemaker programming between 60 and 90 beats per minute will be performed using the myPACE algorithm.
他の名前：
|
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 |
|---|---|---|
|
Change in Montreal Cognitive Assessment Total Score
時間枠：Baseline to 3 months after pacemaker implantation
|
Change in Montreal Cognitive Assessment total score from baseline to 3 months after pacemaker implantation will be compared between participants randomized to standard pacemaker programming at 60 beats per minute and participants randomized to physiologic pacemaker programming between 60 and 90 beats per minute using the myPACE algorithm.
The Montreal Cognitive Assessment is scored from 0 to 30, with higher scores indicating better cognitive function.
|
Baseline to 3 months after pacemaker implantation
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Short Form 36 Health Survey Mental Component Summary Score
時間枠：Baseline to 3 months after pacemaker implantation
|
Change in Short Form 36 Health Survey Mental Component Summary score from baseline to 3 months after pacemaker implantation will be compared between participants randomized to standard pacemaker programming at 60 beats per minute and participants randomized to physiologic pacemaker programming between 60 and 90 beats per minute using the myPACE algorithm.
The Short Form 36 Health Survey Mental Component Summary score ranges from 0 to 100, with higher scores indicating better mental health and psychological well-being.
|
Baseline to 3 months after pacemaker implantation
|
協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Selma Carlson, MD、University of Minnesota
- 主任研究者：Markus Meyer, MD、University of Minnesota
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
本研究に関する用語
その他の研究ID番号
- CV-2026-34972
- STUDY00028711 (その他の識別子：University Of Minnesota)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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