Influence of Intensive Lipid-lowering With Statin and Ezetimib Prescription on Computed Tomography Derived Fractional Flow Reserve in Patients With Stable Chest Pain (The FLOW-PROMOTE Study)
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- 18-month change in coronary flow
研究概览
简要总结
The FLOW-PROMOTE Study is an investigator-initiated, Danish multicenter study of patients with stable chest pain investigating whether lipid lowering is associated with recovery of impaired coronary flow as assessed by CT derived fractional flow reserve (FFRCT).
详细描述
Multicenter study (4 centers in Denmark), including 120 patients with stable chest pain and hemodynamically significant coronary artery disease as assessed by FFRCT. By using two lipid lowering treatment strategies ("usual" vs "intensive" care) over 18 months, the effect on coronary plaque regression and flow recovery are assessed from repeated CT angiograms with plaque and FFRCT analyses at 9 and 18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Open label design
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms suggestive of stable coronary artery disease (CAD)
- •No known CAD
- •At least one coronary stenosis with >49% lumen reduction determined by CT angiography
- •Sinus rhythm
- •At least one lesion with FFRCT <0.81 (see below)
- •Life expectancy >3 years
- •Fertile women must use safe contraception throughout the study period
- •Signed informed consent
- •LDL cholesterol >2.0 mM (patients already on lipid lowering medical therapy < 3 months can be included if meeting all of the above mentioned criteria)
排除标准
- •Unstable angina
- •Body mass index >40
- •Allergy to iodinated contrast media
- •Known statin intolerance
- •Poor coronary CT angiography image quality inadequate for FFRCT calculation (determined by core-laboratory)
- •Significant left main coronary artery (stenosis >49%) or three-vessel CAD determined by coronary CT angiography leading to direct referral to ICA
- •FFRCT <0.81 over the left main coronary artery or the proximal left anterior descendens artery (LAD) segment, or <0.76 over the mid-LAD, proximal circumflex, right coronary artery or intermediate coronary segments
- •Pregnancy (women with age >45 will be screened for pregnancy)
- •Moderate to severe liver failure
- •Estimated glomerular filtration rate (eGFR) < 60 ml/min
- •Participation in another trial
- •Does noes not wish to participate
研究组 & 干预措施
"Usual care"
"Usual care" prevention: atorvastatin 40 mg per day for 18 months
干预措施: Rosuvastatin 40mg (Drug)
"Intensive care"
"Intensive care" prevention: rosuvastatin 40 mg + ezetimib 10 mg per day for 18 months
干预措施: Rosuvastatin 40mg (Drug)
结局指标
主要结局
18-month change in coronary flow
时间窗: 18 months
Coronary flow will be assessed by repetitive FFRCT assessments (0,9 and 18 months)
次要结局
- 18-month change high risk coronary plaque volumes(18 months)
- 18-month change in high risk coronary plaque features(18-months)
- 18-month change in coronary vessel volumes(18-months)
- 18-month change in indices of coronary inflammation(18-months)
研究者
Bjarne Linde Noergaard
Associate Professor, MD, PhD, FESC
Aarhus University Hospital Skejby