A study to find out hardening of heart muscles on radiological (CT scan) images of patients undergoing major cancer surgeries of chest and abdomen and to see its impact on consequences of surgery.
- Conditions
- Malignant neoplasms of digestive organs,
- Registration Number
- CTRI/2019/02/017838
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
**INTRODUCTION and BACKGROUND**:
Cardiovascular disease (CVD) is the most frequent cause ofdeath globally. Of these deaths, a majority are due to coronary heart disease.The incidence of coronary artery disease (CAD) and cancer have increased owingto changing Lifestyle and environmental modifications. Thishas occurred in the developed world and is occurring in the developing countries.Patients with CAD are at increased risk of major cardiac events in theperioperative period.
Anaesthesia and perioperativeperiod is associated with high demand on cardiovascular system. Major noncardiac surgery is associated with perioperative cardiac mortality of 0.5-1.5%and major cardiac morbidity of 2-3.5%. This risk increases significantlywith underlying CAD. Intraperitoneal, intrathoracic , head and neck surgeries,major urological procedures, neurosurgeries and major orthopaedic surgeries arelabelled as intermediate risk surgeries as they are associated with 1-5%incidence of cardiac death and non-fatal myocardial infarction within 30 daysof surgery. Patients undergoing major cancer surgeries are generally elderlywith risk factors for coronary artery disease and low dose standard lung C.T.scans that are done as a standard of care as part of the pre-operativeevaluation can give information about the coronary artery calcium (CAC)deposition. As part of anaesthesia workup most of these patients undergofurther cardiac evaluation in form of stress test (either treadmill test ordobutamine stress ECHO)
Multiple predictors of the severity of CVD are available,the most effective of them being Coronary Artery Calcification (CAC). Detection of coronary artery calcification(CAC) is a strong predictor of CAD, cardiovascular events, and all-causemortality. CAC is usually quantified on dedicated 3 mm sliced computed tomography(CT) scans that are electrocardiography (ECG) gated, so as to minimize motionartifact from the beating heart and provide relatively fine cuts from thebeating heart. Patients posted forCancer surgeries undergo standard 6 mm chest CTs for metastatic workup, but CACis not usually quantified. Calciumwithin the coronary arteries can be easily recognized on these scans, and priorstudies have evaluated CAC on lung CTs for CAD screening in smokers at highrisk for lung cancer.
CAC is a marker of the presence and severity of coronary atherosclerosis.Its presence in asymptomatic subjects indicates the existence of subclinicalcoronary artery disease (CAD). TheAmerican College of Cardiology Foundation (ACCF) and American College ofCardiology (AHA) in 2010 gave class IIa recommendation for measurement of CACfor cardiovascular risk assessment in asymptomatic adults at intermediate risk. In 2012 European Society of Cardiology awarded a similar class IIarecommendation, and suggested CAC for CV risk assessment in asymptomatic adultsat moderate risk.
Generally CAC is reportedusing Agatston score which is a semi-automated tool to calculate a score basedon the extent of coronary artery calcification detected by an unenhancedlow-dose CT scan in patients undergoing cardiac CT. It allows for an early riskstratification as patients with a high Agatston score (>160) have anincreased risk for a major adverse cardiac event (MACE). Ordinal scoring byShemesh et al has shown very good correlation with Agatston scoring forprediction of outcome of cardiovascular disease.
Our study aims torecognize the incidence and severity of CAC on standard CT chest by using thevisual scale and then correlate these scores with the patients’ clinicalcondition preoperatively as well as the intraoperative and postoperativecardiac events. The visual categorization of this CAC in four categories can begenerated for risk assessment of CHD and is strongly associated with theoutcome.
Coronary arterycalcification (CAC) will be assessed and categorized as:
i) Visual Score = 0 – No CAC detected
ii) Visual Score = 1 to 4 – Mild CAC
iii) Visual Score = 5 to7 – Moderate CAC
iv) Visual Score = 8 to 12 Severe CAC
The visual scoringcorrelates well with the dedicated CAC scoring like Agatston scoring and mightpredict clinically significant CAC. Each of the four main coronary arterieswill be identified (left main, left anterior descending, circumflex, andright). Calcification in each artery will be categorized as absent, mild,moderate, or severe and scored by the radiologist as 0, 1, 2, or 3,respectively. Calcification is classified as mild when less than one-third ofthe length of the entire artery shows calcification, moderate when one-third totwo-thirds of the artery shows calcification, and severe when more thantwo-thirds of the artery shows calcification. With four arteries thus scored,each subject receives a CAC score ranging from 0 to 12.
When predicting theperioperative complications, the CAC will be correlated with certain otherfactors to provide a more wholistic report. These include the revised cardiacRisk index, and the NYHA scoring system preoperatively.
Lees Revised Cardiac RiskIndex- Each risk factor is assigned one point.
1. High-risk surgicalprocedures
-Intraperitoneal
-Intrathoracic
-Supra-inguinal vascular
2. History of ischemicheart disease
-History of myocardial infarction
-History of positive exercise test
-Current complain of chest pain considered secondary to myocardial ischemia
-Use of nitrate therapy
-ECG with pathological Q waves
3. History of congestiveheart failure
-History of congestive heart failure
-Pulmonary edema
-Paroxysmal nocturnal dyspnea
-Bilateral rales or S3 gallop
-Chest radiograph showing pulmonary vascular redistribution
4. History ofcerebrovascular disease
-History of transient ischemic attack or stroke
5. Preoperative treatmentwith insulin
6. Preoperative serumcreatinine > 2.0 mg/dL
**RISK OF MAJOR CARDIAC EVENT**
Points Class Risk
0 I 0.4%
1 II 0.9%
2 III 6.6%
3 or more IV 11%
**NYHA classification**
I-No limitation ofphysical activity. Ordinary physical activity does not cause undue fatigue, palpitation,dyspnea (shortness of breath).
II- Slight limitation ofphysical activity. Comfortable at rest. Ordinary physical activity results infatigue, palpitation, dyspnea (shortness of breath).
III- Marked limitation ofphysical activity. Comfortable at rest. Less than ordinary activity causesfatigue, palpitation, or dyspnea.
IV- Unable to carry on anyphysical activity without discomfort. Symptoms of heart failure at rest. If anyphysical activity is undertaken, discomfort increases.
Intraoperative andPostoperative cardiac events will be recorded as
1. Has the patientundergone diagnostic test or therapy during present admission for any of the following?
a. new MI
b. Ischameia orhypotension requiring drug therapy or fluid therapy (fluid bolus >1lt over 2hours or fluid infusion >200ml/hr)
c. Atrial or Ventriculararrhythmias
d. new ECHO findings
e. cardiogenic pulmonaryedema or addition of new anticoagulation
The patients will befollowed up until discharge from the hospital.
**AIMS and OBJECTIVES**:
**PRIMARY OBJECTIVE**: To Assess the frequencyand severity of CAC on standard CT chest in patients undergoing major thoracic,hepatic and pancreatic surgeries and its grading based on Visual score.
**SECONDARY OBJECTIVE**: To correlate the severityof the CAC on patients clinical condition, investigations preoperatively,intraoperatively and postoperatively.
**MATERIALS and METHODS**:
Type of study: Prospective observational study asa part of dissertation at TMH, Mumbai
**Inclusion criteria**: All patients above 18years of age undergoing major thoracic, pancreatic and hepatic surgeries where standardCT thorax is part of a regular pre operative investigation.
**Exclusion criteria**: Paediatric patients (underthe age of 18 years).
Patients deemed inoperable.
**METHODOLOGY:**
After obtaining approval from hospital ethicscommittee, short informed consent will be obtained from patients fulfilling thecriteria. Patients undergoing CT thorax as a routine pre operativeinvestigation will be evaluated for coronary artery calcification and gradedaccording to the visual scale by the radiologist . The demographic profile ofconsenting patient will be recorded i.e. age, sex, ASA physical status, weight,BMI, surgery, NYHA class will be noted. Preoperative investigations and optimizationwill be according to the PAC anesthetist. Patients’ induction & maintenanceof general anaesthesia will be as per the decision of OT anaesthetist.Postoperatively, the patient will be followed up until discharge from thehospital. We will then proceed to corelate the CAC based on the Perioperativecriteria and clinical condition of the patient as stated above.
**STATISTICAL ANALYSIS AND RESULTS:**
There will be no conflict of interest
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
All patients above 18 years of age undergoing major thoracic, pancreatic and hepatic surgeries where standard CT thorax is part of a regular pre operative investigation.
- Paediatric patients (under the age of 18 years).
- Patients deemed inoperable.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of CAC on standard CT chest in patients undergoing major thoracic, hepatic and pancreatic surgeries and its grading based on Visual score Preoperative, intraoperative and postoperative until discharge from the hospital
- Secondary Outcome Measures
Name Time Method Co-relation of the severity of the CAC on patients clinical condition, investigations preoperatively, intraoperatively and postoperatively. Preoperative, intraoperative and postoperative until discharge from the hospital
Trial Locations
- Locations (1)
Tata Memorial Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Tata Memorial Hospital🇮🇳Mumbai, MAHARASHTRA, IndiaDr Vijaya PatilPrincipal investigator9819883535vijayappatil@yahoo.com