Microvascular Resistance Reserve Assessment Derived From Absolute Flow and Resistance by PET and CT
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Agreement non-invasive and invasive MRR
研究概览
简要总结
The goal of this clinical trial is to compare non-invasive myocardial perfusion reserve (MRR) to invasively measured MRR in patients suspected for coronary artery disease (CAD).
The main question it aims to answer is:
• what is the correlation and agreement between non-invasive and invasive MRR.
Participants suspected for CAD and referred for invasive coronary angiogram (ICA) will receive a [15O]H2O-PET and coronary CT angiography preceding ICA. During ICA, microvascular resistance measurements will be performed using thermodilution.
详细描述
Rationale:
In at least 25% - 50% of patients with chest pain, myocardial ischemia can be present without angiographic evidence of significant epicardial disease. In such patients, it is often assumed that the microvasculature of the myocardium is abnormal, called coronary microvascular dysfunction (CMD). This microvascular dysfunction constitutes a diagnostic and therapeutic problem with considerable morbidity and associated functional limitations, reduces quality of life, impairs outcome, and increases economic burden for healthcare systems. In the last years, a new invasive methodology has been developed for true quantitative investigation of the coronary microcirculation by calculation of the microvascular resistance reserve (MRR). Non-invasively, calculating the MRR is also possible by measuring resting and hyperemic myocardial blood flow (MBF), for example using quantitative Positron Emission Tomography (PET). However, non-invasive MRR can only be calculated by PET alone in the complete absence of any epicardial disease (i.e. a Fractional Flow Reserve [FFR] of 1.0). In order to obtain information on epicardial disease without using invasive interrogation of the coronary arteries, a method has been developed by HeartFlow Inc. to combine PET and FFR calculated from Coronary Computed Tomography Angiography (FFRCT). Using this method, MRR can be calculated non-invasively regardless of the presence of epicardial disease. However, non-invasive MRR has never been validated against invasively measured MRR.
Objective:
The main objective is to compare non-invasive MRR, obtained using PET and FFRCT (CT-scanning), with invasively measured MRR measurement using continuous thermodilution.
Study design:
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referred for ICA because of suspected CAD
- •No documented prior history of CAD
- •Age ≥18 and ≤80 years old
排除标准
- •Unstable CAD, Non-ST-Elevation Myocardial Infarction (NSTEMI), ST-Elevation Myocardial Infarction (STEMI), cardiogenic shock or hemodynamically unstable patients
- •Patients with previous coronary artery bypass (CABG) surgery, PCI or myocardial infarction (MI)
- •Tortuous or calcified coronary arteries, if known
- •Coronary arteries with a small caliber (<2,5 mm), if known
- •Atrial fibrillation, second or third degree atrioventricular block or severe conduction disturbances with an indication for temporary or permanent pacing
- •History of severe COPD or chronic asthma
- •Renal failure ( i.e. eGFR < 30 mL/min)
- •Use of sildenafil (Viagra) or dipyramidol (Persantin) that cannot be terminated
- •Contra-indications for β-blockers
- •Allergic reaction to iodized contrast
- •Inability to understand and give informed consent
结局指标
主要结局
Agreement non-invasive and invasive MRR
时间窗: Immediately after the PET and CT scan (non-invasive MRR) and ICA (invasive MRR)
The first primary endpoint will be agreement between non-invasive and invasive MRR, indicated by a Blant-Altman analysis.
Correlation non-invasive and invasive MRR
时间窗: Immediately after the PET and CT scan (non-invasive MRR) and ICA (invasive MRR)
The first primary endpoint will be correlation between non-invasive and invasive MRR, indicated by Pearson/Spearman correlation.
次要结局
- Correlation non-invasive and invasive resting and hyperemic resistance(Immediately after the PET and CT scan (non-invasive MRR) and ICA (invasive MRR))
- Agreement non-invasive and invasive resting and hyperemic resistance(Immediately after the PET and CT scan (non-invasive MRR) and ICA (invasive MRR))
研究者
Paul Knaapen
Prof. Dr. P. Knaapen
Amsterdam UMC, location VUmc