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治験 NCT06644651 (PCAT-DM)（対象：冠動脈硬化症、糖尿病、2型糖尿病、炎症、Inflammation Plaque, Atherosclerotic、Perivascular Disease）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
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Fat Around Heart Arteries as a Measure of Inflammation in Patients With Diabetes (PCAT-DM) 314
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 NCT06644651 (PCAT-DM) は 観察研究 臨床試験 で、冠動脈硬化症、糖尿病、2型糖尿病、炎症、Inflammation Plaque, Atherosclerotic、Perivascular Disease を対象とした研究でした。現在は 完了 です。2016年3月1日 に開始し、314 名の参加者 が参加しました。この試験は Odense University Hospital によって主導され、2025年3月1日 に完了しました。ClinicalTrials.gov からの最新更新日は 2025年7月31日 です。
概要
In this prospective study, the objective is to investigate inflammation in the arteries of the heart. A heart CT scan (CCTA) will be used to measure inflammation by assessing the fat tissue surrounding the arteries of the heart. Participants with type 2 diabetes who have no heart symptoms have been examined, using a CCTA at the start of the study and again after 12 months.
This study aims to answer the following que...
もっと見る詳細説明
Background and significance:
Inflammation in the coronary arteries plays a significant role in the development of heart disease, particularly in individuals with type 2 diabetes (T2D), who are at an increased risk. However, this inflammation has been difficult to detect because the currently used biomarkers have limited accuracy in identifying inflammation in the coronary arteries.
Exiting advancements have been ma...
もっと見る公式タイトル
Prospective Associations of Pericoronary Adipose Tissue Computed Tomography Attenuation With Coronary Plaque Features and Major Adverse Cardiovascular Events in a Population With Diabetes Mellitus
疾患名
冠動脈硬化症糖尿病2型糖尿病炎症Inflammation Plaque, AtheroscleroticPerivascular Disease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
- PCAT-DM
NCT番号
開始日
2016-03-01
最終更新日
2025-07-31
終了予定日
2025-03-01
目標参加者数
314
試験の種類
観察研究
状況
完了
キーワード
Atherosclerotic Plaque
Coronary artery disease
Atherosclerosis, coronary
Inflammation
Pericoronary adipose tissue
Coronary inflammation
Type 2 Diabetes Mellitus
Coronary artery disease
Atherosclerosis, coronary
Inflammation
Pericoronary adipose tissue
Coronary inflammation
Type 2 Diabetes Mellitus
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
Participants with type 2 diabetes mellitus The study population consists of participants with type 2 diabetes mellitus who are cardiac asymptomatic and have no known coronary heart disease. Participants underwent a baseline examination and CCTA scan, followed by a 12-month visit with repeated examinations and a second CCTA scan. A journal audit will be conducted for all participants approximately 7 years after the baseline CCTA scan. | 該当なし |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Baseline PCAT attenuation and plaque features at the 12-month CCTA | Cardiac assessments at the 12-month CCTA scan include:
Plaque composition, measured by the volume of different plaque types. Plaque burden is measured as compositional plaque volume adjusted by vessel length (normalized atheroma volume).
High-risk plaque features assessed include positive remodeling (PR), low-attenuated plaque (LAP), napkin-ring sign (NRS), and spotty calcifications (SC). | 12 months |
Changes in PCAT attenuation and plaque features at the 12-month CCTA | Changes in PCAT attenuation from baseline to the 12-month CCTA will be measured.
Cardiac assessments at the 12-month CCTA scan include:
Plaque composition, measured by the volume of different plaque types. Plaque burden is measured as compositional plaque volume adjusted by vessel length (normalized atheroma volume). High-risk plaque features assessed include positive remodeling (PR), low-attenuated plaque (LAP), napkin-ring sign (NRS), and spotty calcifications (SC). | 12 months |
Baseline PCAT attenuation and MACE | Baseline PCAT attenuation will be used to predict major adverse cardiovascular (CV) events (MACE), including CV death, non-fatal acute myocardial infarction (AMI), non-fatal stroke, heart failure (HF) de novo, and hospitalization for HF, over a 7-year period following the CCTA scan. | 7 years |
Changes in PCAT attenuation after 12-month and MACE | Changes in PCAT attenuation from baseline to the 12-month CCTA scan will be used to predict major adverse cardiovascular (CV) events (MACE), including CV death, non-fatal acute myocardial infarction (AMI), non-fatal stroke, heart failure (HF) de novo, and hospitalization for HF, over a 7-year period following the CCTA scan. | 7 years |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
PCAT attenuation and de novo heart failure | Baseline PCAT attenuation will be used to predict de novo heart failure over a 7-year period following the CCTA scan. | 7 years |
PCAT attenuation and non-fatal acute myocardial infarction | Baseline PCAT attenuation will be used to predict non-fatal acute myocardial infarction (AMI) over a 7-year period following the CCTA scan. | 7 years |
PCAT attenuation and non-fatal stroke | Baseline PCAT attenuation will be used to predict non-fatal stroke over a 7-year period following the CCTA scan. | 7 years |
PCAT attenuation and hospitalization for HF | Baseline PCAT attenuation will be used to predict hospitalization for heart failure (HF) over a 7-year period following the CCTA scan. | 7 years |
PCAT attenuation and CV death | Baseline PCAT attenuation will be used to predict cardiovascular (CV) death over a 7-year period following the CCTA scan. | 7 years |
PCAT attenuation and PAD | Baseline PCAT attenuation will be used to predict peripheral artery disease (PAD) over a 7-year period following the CCTA scan. | 7 years |
PCAT attenuation and CV revascularization | Baseline PCAT attenuation will be used to predict CV (cardiovascular) revascularization over a 7-year period following the CCTA scan. | 7 years |
PCAT attenuation and all-cause mortality | Baseline PCAT attenuation will be used to predict all-cause mortality over a 7-year period following the CCTA scan. | 7 years |
Changes in PCAT attenuation and non-fatal acute myocardial infarction | Changes in PCAT attenuation from baseline to the 12-month CCTA scan will be used to predict non-fatal acute myocardial infarction (AMI) over a 7-year period following the baseline CCTA scan. | 7 years |
Changes in PCAT attenuation and hospitalization for HF | Changes in PCAT attenuation from baseline to the 12-month CCTA scan will be used to predict hospitalization for heart failure (HF) over a 7-year period following the baseline CCTA scan. | 7 years |
Changes in PCAT attenuation and non-fatal stroke | Changes in PCAT attenuation from baseline to the 12-month CCTA scan will be used to predict non-fatal stroke over a 7-year period following the baseline CCTA scan. | 7 years |
Changes in PCAT attenuation and PAD | Changes in PCAT attenuation from baseline to the 12-month CCTA scan will be used to predict peripheral artery diasease (PAD) over a 7-year period following the baseline CCTA scan. | 7 years |
Changes in PCAT attenuation and CV death | Changes in PCAT attenuation from baseline to the 12-month CCTA scan will be used to predict cardiovascular (CV) death over a 7-year period following the baseline CCTA scan. | 7 years |
Changes in PCAT attenuation and CV revascularization | Changes in PCAT attenuation from baseline to the 12-month CCTA scan will be used to predict cardiovascular (CV) revascularization over a 7-year period following the baseline CCTA scan. | 7 years |
Changes in PCAT attenuation and all-cause mortality | Changes in PCAT attenuation from baseline to the 12-month CCTA scan will be used to predict all-cause mortality, over a 7-year period following the baseline CCTA scan. | 7 years |
Changes in PCAT attenuation and de novo heart failure | Changes in PCAT attenuation from baseline to the 12-month CCTA scan will be used to predict de novo heart failure (HF) over a 7-year period following the baseline CCTA scan. | 7 years |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- Above 18 years
- Capable of giving written informed consent
- Type 2 diabetes mellitus
- History of CAD
- Symtoms of CAD (angina)
- Any tachyarrhythmias making CCTA impossible
- Estimated glomerular filtration rate (eGFR) under 45 ml/min
- Allergy to iodine contrast
- Critical illness with life expectancy less than 1 year
- Documented heart failure
Odense University Hospital連絡先情報がありません。
1 1カ国の場所
Region Syddanmark
Cardiovascular Research Unit, Svendborg, Region Syddanmark, 5700, Denmark