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治験 NCT05237271（対象：心血管疾患、2型糖尿病）は完了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Clinical Utility Trial for the SomaLogic CVD-T2D Test 251 無作為化
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT05237271 は 介入研究 臨床試験 で、心血管疾患、2型糖尿病 を対象とした研究でした。現在は 完了 です。2022年3月15日 に開始し、251 名の参加者 が参加しました。この試験は Qure Healthcare, LLC によって主導され、2022年8月15日 に完了しました。ClinicalTrials.gov からの最新更新日は 2022年8月22日 です。
概要
QURE will use its CPV technology in a randomized controlled trial to measure how SomaLogic's diagnostic test (the Cardiovascular Disease in Type 2 Diabetes) changes clinical practice and improves patient outcomes.
詳細説明
SomaLogic has developed a pioneering technology, the SomaScan® Platform, the first and only platform, that simultaneously measures 7,000 proteins. The company's technology is based on proprietary aptamers, called SOMAmers®, which can measure these unique proteins with high sensitivity and specificity across a large dynamic range. Using over 60,000 samples, artificial intelligence and machine learning powered bioinfor...もっと見る
公式タイトル
Establishing Clinical Utility Evidence to Support Coverage and Reimbursement for SomaLogic's Cardiovascular Disease in Type 2 Diabetes Test: A CPV® Randomized Controlled Trial
疾患名
心血管疾患2型糖尿病刊行物
この臨床試験について発表された科学記事と研究論文：その他の研究識別子
- Pro00058735
主目的
診断
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
非介入Control Group Control group treats their simulated patients using standard practice and have no introduction to the new SomaLogic test. | 該当なし |
実験的Intervention Group 1 Intervention group 1 will receive educational materials on the single cardiovascular disease in type 2 diabetes risk score. They will then be forced to used the risk score for their simulated patients, which will allow us to assess how the risk score may improve clinical practice and reduce variation. | Educational Materials on the Cardiovascular Disease in Type 2 Diabetes (CVD-T2D) Educational Materials will detail the diagnostic tests in question. This CVD-T2D will provide a numerical risk score for the likelihood of patients with type 2 diabetes to have a cardiovascular event in the next 4 years. |
実験的Intervention Group 2 Intervention group 2 will receive educational materials on the cardiovascular disease in type 2 diabetes (CVD-T2D) risk score as well as the panel of metabolic scores. They will then be forced to used the CVD-T2D score and the metabolic panel scores for their simulated patients, which will allow us to assess how the risk score may improve clinical practice and reduce variation. | Educational Materials on the Cardiovascular Disease in Type 2 Diabetes (CVD-T2D) Educational Materials will detail the diagnostic tests in question. This CVD-T2D will provide a numerical risk score for the likelihood of patients with type 2 diabetes to have a cardiovascular event in the next 4 years. Educational Materials on the CVD-T2D and Bundled Metabolic Panel Educational Materials will detail the diagnostic tests in question.his CVD-T2D will provide a numerical risk score for the likelihood of patients with type 2 diabetes to have a cardiovascular event in the next 4 years. The bundled metabolic scores will provide insight into the patient's current metabolic conditions. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
CPV-measured clinical score difference | Difference-in-differences regression analysis between the control and the intervention groups' physicial exam, workup, diagnosis, and treatment cardiovascular risk in patients with type 2 diabetes, as measured by the participants diagnostic and treatment CPV case domain scores. In each CPV, participants' care recommendations are evaluated against evidence-based care scoring criteria which can sum from 0 to a high potential score of up to 100 percent in each domain, where higher scores mean better outcomes. We will measure the overall change in the evidence-based physician behavior including referrals, utilization of cardioprotective medications, right heart catherization and echocardiography, in the CPV patient simulations. | 12 Months |
CPV-measured cost difference | Change in cost of related care for cardiovascular risks in patients with diabetes mellitus when comparing the control to the intervention group. (This cost is modeled in part by measuring differential rates of medical interventions selected by each arm and multiplying by average Medicare reimbursement rates for these interventions. The cost is also modeled by examining average per annum costs for patients suffering from diabetes mellitus and multiplying by the percent of patients whose workup and interventions for cardiovascular risks are significantly reduced following the intervention.) | 12 Months |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
CPV-measured baseline clinical variation levels | Participants completing the simulated cases, or CPVs, receive scores based upon the quality of care they provide. This measure will assess the baseline levels of variation in the care of pain patients among all participants, including by use case types. We will measure the baseline levels of variation in the assessment, recognition, and management of cardiovascular risks in patients with diabetes mellitus among all participants. | 12 Months |
CPV-measured Assessment of use case types | Difference in the overall, and the diagnostic and treatment quality scores between control and intervention participants. Diagnostic and treatment scores are calculated as the percent correct on CPVs, and the overall score is a average score of the subcategory scores (percent correct). This will be examined for each of the use cases to determine in which case(s) CPV scores most improved. | 12 Months |
適格基準
対象年齢
小児, 成人, 高齢者
対象性別
全て
- Board-certified primary care physicians or cardiologist for at least two years
- Averaging at least 20 hours per week of clinical and patient care duties over the last six months
- Routinely evaluate patients with diabetes mellitus in their practice
- Practicing in the U.S.
- English speaking
- Access to the internet
- Informed, signed and voluntarily consented to be in the study
- Non-English speaking
- Practicing in an academic setting
- Unable to access the internet
- Not practicing in the U.S.
- Not averaging at least 20 hours per week of clinical or patient care duties over the last six months
- Previous exposure to the CVD-T2D test
- Do not voluntarily consent to be in the study
Qure Healthcare, LLCSomaLogic, Inc.連絡先情報がありません。
1 1カ国の場所
California
QURE Healthcare, San Francisco, California, 94133, United States