Risk Evaluation and Stratification of Low Risk for Cardiovascular Disease in Women: An Innovative Strategy for Investigating Stable Chest Pain in Low to Intermediate Risk Women
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Total Number of Tests
研究概览
简要总结
This study will evaluate the ability of Coronary Computed Tomography Angiography (CCTA), used as a first-line diagnostic tool in women with stable chest pain and low risk for Coronary Artery Disease (CAD), to reduce the number of women requiring more than one diagnostic test to rule in or rule out CAD. Half of the participants will undergo CCTA as the first test to investigate stable chest pain, while the other half will undergo any test ordered by their family physician.
详细描述
Coronary artery disease (CAD) is the leading cause of death in women globally. Women are more likely to present with atypical chest pain that may be difficult to diagnose using traditional testing methods, resulting in over-investigation.
Coronary computed tomography angiography (CCTA) has high negative predictive value for exclusion of CAD in low to intermediate risk populations. We plan to investigate CCTA as a first line test to exclude coronary artery disease as a cause of stable chest pain and whether it is a cost effective strategy that reduces time to diagnosis, wait times to see cardiologists, emergency department visits, downstream and repeat testing and radiation exposure as compared to usual care with comparable patient safety and satisfaction level.
Another intervention being tested in this trial is the Cardiac Link pathway. This is a new clinical program at Women's College Hospital that aims to expedite cardiology referral for patients exhibiting clinically significant findings while undergoing CCTAs.
We hope that with use of CCTA as the first test, the number of women who require only one test (i.e. CCTA) to sort out whether or not CAD is responsible for their chest pain will increase, thereby decreasing over-investigation of low risk women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Men and women age ≥ 40 years of age
- •Stable chest pain or equivalent symptoms
- •Planned non-urgent, non-invasive testing for diagnosis of chest pain or equivalent symptoms
排除标准
- •Acute coronary syndrome, including acute myocardial infarction or unstable angina, known non-ischemic cardiomyopathy or other cardiac disease (e.g. mitral valve prolapse, etc.) which would require urgent cardiac evaluation
- •Known CAD
- •Prior cardiac evaluation for current episode of symptoms
- •Previously investigated for CAD in the last 12 months
- •Severe allergic reaction to iodinated contrast (mild reactions such as urticaria that can be controlled by premedication with Benadryl & Prednisone may be included in the study)
- •Renal failure or dysfunction (estimated Glomerular Filtration Rate<30ml/min/m2 within the past 3 months)
- •Pregnancy (status will be confirmed verbally. For premenopausal patients who are unsure, status will be confirmed by completing a pregnancy strip test).
研究组 & 干预措施
Usual Care with Cardiac Link
Patient will undergo the usual diagnostic test ordered by their family physician as the first test, and have Cardiac Link pathway activated for expedited cardiology referral.
干预措施: Coronary Computed Tomography Angiography (CCTA) (Diagnostic Test)
CCTA first approach with Cardiac Link
Patient will undergo Coronary Computed Tomography Angiography as the first test and have Cardiac Link pathway activated for expedited cardiology referral.
干预措施: Coronary Computed Tomography Angiography (CCTA) (Diagnostic Test)
CCTA first approach with Cardiac Link
Patient will undergo Coronary Computed Tomography Angiography as the first test and have Cardiac Link pathway activated for expedited cardiology referral.
干预措施: Cardiac Link (Other)
CCTA first approach without Cardiac Link
Patient will undergo Coronary Computed Tomography Angiography as the first test, but Cardiac Link pathway will not be activated.
干预措施: Coronary Computed Tomography Angiography (CCTA) (Diagnostic Test)
Usual Care with Cardiac Link
Patient will undergo the usual diagnostic test ordered by their family physician as the first test, and have Cardiac Link pathway activated for expedited cardiology referral.
干预措施: Cardiac Link (Other)
Usual Care without Cardiac Link
Patient will undergo the usual diagnostic test ordered by their family physician as the first test, but Cardiac Link pathway will not be activated.
干预措施: Coronary Computed Tomography Angiography (CCTA) (Diagnostic Test)
结局指标
主要结局
Total Number of Tests
时间窗: Through study completion, which may take up to 1 year
The total number of tests a patient has to complete in order to diagnose the cause of their chest pain or equivalent symptoms
次要结局
- Wait Times to See a Cardiologist(From date of cardiology referral letter sent by family physician to date of cardiologist appointment with patient, assessed up to 24 months)
- Time to Diagnosis(From date of first presentation with chest pain to date of CAD diagnosis or exclusion, assessed up to 24 months)
- Total Cost of Investigations(Through study completion, which may take up to 1 year)
- Cumulative Radiation Dose Exposure (milliSieverts)(From date of randomization to date of CAD diagnosis or exclusion, assessed up to 24 months)
- Hospital/ER visits(Through study completion, which may take up to 1 year)
- Number of Normal Invasive Diagnostic Angiograms(From date of randomization to date of CAD diagnosis or exclusion, assessed up to 24 months)
研究者
Elsie Nguyen
Associate Professor of Radiology
Women's College Hospital