Role of the Cardioflux Magnetocardiography System in Predicting Patient Outcomes With Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Percentage study subjects having coronary Revascularization
研究概览
简要总结
This single-center clinical trial is designed to evaluate the CardioFlux magnetocardiograph diagnostic imaging system to predict major adverse cardiac events (MACE) in patients referred for evaluation for coronary artery disease.
详细描述
This is a single-center, prospective, observational cohort trial to form a registry data set. Patients presenting for cardiac stress testing utilizing Single Photon Emission Computed Tomography (SPECT), cardiac CT angiography (CCTA), or cardiac catheterization will be offered to enroll in the registry and provide informed consent to undergo imaging with a CardioFlux magnetocardiography (MCG) prior to their procedure.
Multiple studies have shown that MCG accuracy is quite high in identifying patients with symptomatic coronary artery disease. This difference is dramatic enough to prove superiority over standard ECGs in diagnosis of vital ischemic and infarction parameters. Genetesis presents a novel MCG analysis system called CardioFlux (CF). This modality takes less than five minutes to complete, is radiation-free, and is an easy to operate system. This clinical trial will enroll patients of all cardiac risk levels presenting for various modalities of cardiac diagnostic testing to have CardioFlux scanning in addition to standard of care. Results will be interpreted and compared to the immediate results of nuclear (SPECT) stress testing, cardiac CT angiography, or cardiac catheterization.
Participants will be followed up at 30 days and 1 year via phone call or chart review. 30 day and 1 year MACE will be recorded and correlated with initial CardioFlux MCG results. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall accuracy will be calculated of CardioFlux relative to the incidence of MACE, and in comparison to the above diagnostic modalities.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age at the time of enrollment.
- •Patient presenting for cardiac stress testing, cardiac CT angiography (CCTA), or cardiac catheterization.
- •Consents to having an magnetocardiogram-CardioFlux study scan.
排除标准
- •< 18 years of age
- •Patients unable to fit into device
- •Non-ambulatory patients
- •Patients with implanted cardiac pacemakers/defibrillators
- •Positive response on provided Metallic/Ferromagnetic Device Screening Form
- •Atrial fibrillation with rapid ventricular response
- •Patients with other sustained or incessant arrhythmias
- •Patients with claustrophobia or unable to lie supine for 2 minutes
- •Patients require supplemental oxygen at home
- •Presence or reasonable clinical suspicion of any acute coronary syndrome for which delayed intervention could increase the risk or magnitude of damaged myocardium
- •Patients scheduled for cardiac catheterization with indication of valvular disease
- •Poor candidate for follow-up (e.g. no access to phone)
- •Prisoners
- •Repeat participants
- •Patients participate in other research studies
结局指标
主要结局
Percentage study subjects having coronary Revascularization
时间窗: 1 year
Patient follow up will be performed to find the incidence of coronary revascularization at 30 days and 1 year.
Percentage of study subjects having Major Adverse Cardiac Events
时间窗: 1 year
Patients will have follow up to determine the occurrence of MACE, defined as nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death
Incidence of study subjects with endpoint of death
时间窗: 1 year
All cause mortality will be recorded at end of follow up period for the entire study population.
次要结局
- Comparison of MCG with Cardiac CT angiography (CCTA)(30 days)
- Comparison of MCG with Stress testing(30 days)