A Prospective, Randomized Trial of Early Revascularization in Stable Ischemic Heart Disease Guided by Positron Emission Tomography of Artery Specific Integrated Comprehensive Quantitative Myocardial Perfusion
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change from baseline in the % of left ventricle (LV) with Coronary Flow Capacity (CFC)blue.
研究概览
简要总结
To compare the impact of revascularization and Optimal Medical Treatment (OMT) on the extent of severely reduced coronary flow capacity in stable ischemic heart disease.
详细描述
The initial Positron Emission Tomography (PET) scan will be performed as part of clinical practice. If the patient is a potential candidate for the study, the patient will be screened for inclusion and exclusion criteria. After being informed about the study potential risks, all patients giving written informed consent will be randomized into one of two groups: Urgent revascularization combined with Optimal Medical Treatment (OMT) or OMT with delayed revascularization. Following the initial PET scan, randomization and treatment, each group will undergo a second PET scan at the 3-4 month mark and a third PET scan at the one year mark. Some crossover may occur with the two groups. The OMT without urgent revascularization patients will remain in that group, if clinically stable, up to three months. At their first follow-up visit (Day 105±20), patients will be offered the option of continued medical treatment or elective revascularization consistent with informed patient preference and clinical judgement. Patients, in consultation with their physicians, may elect to undergo revascularization at any time thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Study personnel and subjects will not be blinded. All core lab measurements, comparisons, and statistical analysis will be blinded to group assignment by blinded coding of PET images. Two volunteers who are not involved in the study in any way to create randomization envelopes with each arm. The study staff volunteers for randomization assignment will:
Create a randomization list with two arms (52 per arm). Create 104 sequential envelopes which will contain a paper with the assignment based on the randomization list.
The sequential randomization envelopes will be kept in the site PI's locked office thereby allowing for randomization immediately after consent is obtained. The randomization arm will be shared with the research team and the subject.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Stable ischemic heart disease as determined by an investigator.
- •Areas of severely reduced CFC or relative stress images on the Rentrop diagnostic PET MPI consistent with clinical judgement as follows:
- •PETs with a defect on rest relative images of ≤60% of max for ≤5% of LV (no large scar) plus: i. ≥2% of LV with CFCblue* or ii. ≥10% of LV with CFCgreen* plus at least one pixel with CFCblue*
- •*CFCblue is defined as a dipyridamole induced stress flow ≤ 0.83 ml/min/g of myocardium and a CFR ≤ 1.
- •CFCgreen is defined as a dipyridamole induced stress flow ≤1.09 and >0.83 ml/min/g of myocardium and a CFR ≤1.60 and >1.
- •Willing to comply with the follow-up schedule of the trial.
- •Subject must sign the informed consent in English or Spanish.
排除标准
- •Any conditions that may compromise or prevent the necessary imaging requirements.
- •Less than one-year life expectancy.
- •Currently pregnant or planning to become pregnant during the course of the study.
- •Any other issues that the Investigator believes may interfere with treatment or follow-up.
- •Subjects who lack capacity to consent for themselves.
结局指标
主要结局
Change from baseline in the % of left ventricle (LV) with Coronary Flow Capacity (CFC)blue.
时间窗: Baseline and Day 105+20
CFCblue is defined as a dipyridamole induced stress flow ≤ 0.83 ml/min/g of myocardium and a CFR ≤ 1.27.
Change from baseline in the % of left ventricle (LV) with Coronary Flow Capacity (CFC)green.
时间窗: Baseline and Day 105+20
CFCgreen is defined as a dipyridamole induced stress flow ≤1.09 and \>0.83 ml/min/g of myocardium and a CFR ≤1.60 and \>1.27.
次要结局
- Change in % of LV with CFCblue.(Baseline and Day 105 +20 and Day 365+30)
- Change in minimum quadrant average stress ml/min/g.(Baseline and Day 105 +20 and Day 365+30)
- Change in global CFR.(Baseline and Day 105 +20 and Day 365+30)
- Change in specific iso-contour defect size & its average CFR.(Baseline and Day 105 +20 and Day 365+30)
- Change in DEFECT stress ml/min/g.(Baseline and Day 105 +20 and Day 365+30)
- Rate of procedure-related adverse events(Baseline and Day 105 +20 and Day 365+30)
- Change in DEFECT relative stress.(Baseline and Day 105 +20 and Day 365+30)
- Change in CFC histogram distribution.(Baseline and Day 105 +20 and Day 365+30)
- Rate of adverse events(Baseline and Day 105 +20 and Day 365+30)
- Change in % of LV with CFCgreen.(Baseline and Day 105 +20 and Day 365+30)
- Change in minimum quadrant average CFR.(Baseline and Day 105 +20 and Day 365+30)
- Change in minimum stress relative quadrant average.(Baseline and Day 105 +20 and Day 365+30)
- Changes in an additional 120 PET flow fields.(Baseline and Day 105 +20 and Day 365+30)
- Rate of safety events.(Baseline and Day 105 +20 and Day 365+30)
研究者
K.Lance Gould
Professor
The University of Texas Health Science Center, Houston