A Pilot Study: The Role Of Noninvasive 320-Row Multidetector Computer Tomography Coronary Angiogram In Predicting Perioperative Cardiac Complications In Patients Referred For Noncardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To assess the coronary luminal stenosis for location, number of vessels involved and severity of luminal stenosis using noninvasive CTCA.
研究概览
简要总结
Computer tomography coronary angiogram (CTCA) has emerged as a noninvasive alternative to assessing coronary artery luminal disease. Although the use of noninvasive CTCA for the detection of coronary artery disease is on the rise, the current technology of the 64-row multidetector computer tomography (MDCT) is subjected to multiple patient artifacts that can affect image quality.To eliminate these patient related artifacts a more advanced 320-row MDCT was recently developed. The investigators therefore propose that the newly developed 320-MDCT can provide an accurate noninvasive assessment of the severity of coronary artery luminal stenosis as an alternative to an invasive coronary angiogram.
详细描述
This pilot study consisting of a prospective non-randomized observational trial where a team of surgeon, anesthesiologist, and evaluator are blinded to CTCA results. We hypothesize that the preoperative use of noninvasive computer tomography, with the 320-row MDCT, to visualize the degree of coronary artery stenosis can lead to improved clinical prediction of perioperative cardiac complications.
The 320-row MDCT is based on the 64-row technology with the significant addition of a larger detector capable of scanning the heart within 1 sec or a cardiac cycle, thereby, eliminating patient-related artifacts and may produce higher image quality.13, 14 The scanning time of 5 seconds with the 320-row MDCT is significantly reduced compared to 8-10 seconds for the 64-row MDCT
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
- •Male or female, 18 years and older
- •Able to understand and willing to sign the Informed Consent Form
- •Undergoing vascular surgery or intermediate risk surgery (these include intraperitoneal, intrathoracic, carotid endarterectomy , head and neck, orthopedics or prostate) AND
- •One or more of the following clinical predictors according to the Revised Cardiac Risk Index:
- •history of ischemic heart disease (CABG, MI, Stent, positive stress test, Q-waves on ECG)
- •Diabetes (requiring insulin)
- •history of congestive heart failure (NYHA I- II)
- •history of cerebrovascular disease, any of :
- •history of carotid stenosis
- •history of ischemic cerebrovascular disease (stroke or TIA)
- •Aortic or peripheral vascular disease OR
- •Risk of CAD with 3 or more of the following
- •Age ≥ 70 years
- •Hypertension (medicated)
- •Cholesterol (medicated)
- •Diabetes (medicated-oral hypoglycemic)
- •Family history of coronary artery disease
排除标准
- •Lack of consent for participation
- •History of an allergic response to iodinated contrast medium
- •History of an allergic response, or other contraindication to beta blockers
- •eGFR < 45 mL/min
- •Hemodynamically unstable/compromised
- •Urgent surgery
- •Atrial fibrillation > 80 bpm
- •Uncontrolled tachyarrhythmia
- •Atrioventricular block (second and third degree)
- •Moderate to severe aortic stenosis
- •Not able to hold breath for 5 - 10 seconds
- •History of multiple myeloma or organ transplant
- •Severe pulmonary disease including COPD, PAH, asthma
- •Congestive heart failure presented as NYHA functional class III - IV
- •Severe anemia
- •Increased intracranial pressure
- •Closed angle glaucoma
- •Absolute contraindication to Nitroglycerin
- •Presence of medical condition or history that investigator feels would be problematic
- •Acute myocardial infarction (within 4-6 weeks) -
结局指标
主要结局
To assess the coronary luminal stenosis for location, number of vessels involved and severity of luminal stenosis using noninvasive CTCA.
时间窗: CTCA 1-2 hours
CTCA will be read by a cardiac radiologist blinded to the patients' medical/cardiac history and the results of the stress test. The cardiac radiologist will classify the severity of coronary artery disease according to number of vessels, location and degree of luminal steno-occlusive disease.
次要结局
- Perioperative cardiac complications(In hospital day 0-3, 30 days post surgery and one year)