PET/CT for the Quantification of Atherosclerotic Plaque Inflammation in Patients With Coronary Heart Disease: The QAEK Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Association of FDG uptake and coronary plaque vulnerability
研究概览
简要总结
This is a single-centre prospective trial with 140 patients employing [18F]-fluorodeoxyglucose positron emission computed tomography (FDG PET/CT) and advance motion correction and image fusion algorithms to create motion frozen displays and quantify FDG-uptake and thus inflammatory activity in atherosclerotic plaques in the coronary tree. Four groups of patients, two with stable coronary artery disease and two with acute coronary syndrome will be compared and the results of FDG PET/CT will be correlated to results of invasive coronary angiography, intravascular ultrasound / virtual histology, patient risk profile and serum markers of inflammation.
The investigators hypothesize that increased FDG accumulation in atherosclerotic plaques shows a positive correlation with inflammatory activity in coronary plaques and markers of plaque vulnerability as well as the risk profile of the patients and serum markers of inflammation. The investigators furthermore hypothesize that FDG PET/CT is able to detect high risk patients and provide an important means for risk stratification and optimization of patient management.
详细描述
Currently there are only morphological reference standards to detect vulnerable coronary plaques. However, inflammatory activity and plaque composition predict future cardiovascular events. Thus the aims and objectives of the study are the following:
- Inflammatory activity of the coronary arteries and the great peripheral arteries shall be detected and quantified by means of FDG PET/CT hybrid imaging.
- We aim to develop "motion frozen displays" of the heart and coronary arteries by means of ECG- and respiratory triggering of myocardial motion to reduce motion artifacts.
- We aim to compare the coronary FDG uptake of patients with known stable CAD to the coronary FDG uptake of patients with acute coronary syndrome.
- We aim to correlate coronary PET/CT with intravascular ultrasound (IVUS) / virtual histology (VH), which will be carried out during coronary angiography and provides the gold standard to characterize plaque composition.
- Correlation of the inflammatory activity as measured by PET with the risk profile of the patients, blood coagulability and inflammatory and plaque-associated serum markers to establish a valid risk stratification.
- Follow-up of the patients over at least one year to detect cardiovascular events.
Study Design
This is a prospective single-center study to evaluate coronary FDG PET/CT under controlled and standardized conditions. The study was approved by the local ethical committee as well as the German Federal Authority for Radiation Protection (Bundesamt für Strahlenschutz). All examinations will be performed at the University Hospital of the LMU in Munich. The study is in accordance with the Declaration of Helsinki, all patients provide informed written consent.
We plan to image four study populations with a high risk for inflammatory atherosclerosis or plaque rupture: two groups consist of patients with stable coronary disease and two groups consist of patients with acute coronary syndrome (Figure 1).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •symptomatic patients with known STEMI or NSTEMI and/or known CAD (see patient groups above)
- •written informed consent for blood samples, ICA, IVUS/VH and FDG PET/CT
排除标准
- •less than 50 years of age
- •reason for symptoms other than coronary stenoses / occlusion
- •known contraindication for the above listed examinations (like iodine allergy, intolerance of contrast media, claustrophobia)
- •patients, who are not able to lie still without changing position over a minimum of 45 minutes
- •pregnancy, breast feeding
- •restricted renal function (creatinine > 1,5 mg% in women, > 2mg% in men)
- •surgery within prior 24 hours
结局指标
主要结局
Association of FDG uptake and coronary plaque vulnerability
时间窗: within 72 hours after enrollment
Increased FDG uptake is found in plaques that fulfill the criteria of plaque vulnerability as measured with IVUS/VH.
次要结局
- Association of FDG-uptake and extent of the disease(within 72 hours after enrollment)
- Association of FDG-uptake and risk profile / serum markers(within 72 hours after enrollment)
- Association of FDG-uptake and cardiovascular events(within 1 year of follow-up)
研究者
PD Dr. med. M. Hacker
PD Dr. med. Marcus Hacker
Ludwig-Maximilians - University of Munich