Symptoms and General Pathology

All Conditions

Heart and Blood Diseases

Inflammation

Atherosclerosis

Necrosis

Arteriosclerosis

Arterial Occlusive Diseases

Vascular Diseases

All Drugs and Chemicals

Bone Density Conservation Agents

Calcium

Calcium, Dietary

Andriana Bertolami, MD, PhD

Andrei C Sposito, MD, PhD

Subclinical atherosclerosis is the atherosclerotic process identified before clinical symptoms and thus it can be a useful marker of future cardiovascular events. It can be evaluated by many methods. This study included the diagnosis of subclincal atherosclerosis by four different methods: coronary calcium score, carotid doppler ultrasound to quantify intima media thickness and carotid plaques, exercise stress test and ankle brachial index. Clinical data, anthropometric measures (body mass index, abdominal circumference), markers of inflammation (high sensitive - C reactive protein, TNF alfa and Lipoprotein Associated Phospholipase A2), fat tissue function (leptin, resistin and adiponectin), glucose metabolism (fasting plasma glucose, glycated hemoglobin and insulin) and genetics markers of atherosclerotic process were evaluated as biomarkers of subclinical atherosclerosis in a uneventful population.

This study cross-sectionally evaluated consecutive patients at the outpatient clinic of Dyslipidemia and of Hypertension and Nephrology Medical Sections of Dante Pazzanese Institute of Cardiology, a cardiologic tertiary hospital in São Paulo - Brazil. After they fulfilled inclusion criteria and signed an informed consent, a brief medical history and anthropometric data (abdominal circumference, height and weight for body mass index calculation) were collected. Within of a month after inclusion, all patients underwent blood sample collection for dosing fast plasma glucose and insulin and 2 hours after 75g of dextrose test glucose and insulin, fast serum triglycerides, total cholesterol, HDL cholesterol, creatinine, high sensitive c-reactive protein (hs-CRP), HbA1c, thyroid stimulating hormone (TSH), free thyroxin (fT4), creatine kinase, adiponectin, resistin, leptin, tumor necrosis factor alpha (TNF-α), lipoprotein associated phospholipase A2 (Lp-PLA2). Blood sample was also stored for DNA (rs2383206, rs10757274, rs10757278, rs1051931, rs16874954 and rs1799724) and RNA PLA2G7 (2-ΔCT), TNF-α (2-ΔCT), LEP (2-ΔCT), LEPR (2-ΔCT) extraction and analyses.

Subclinical atherosclerosis was evaluated by four methods: carotid doppler ultrasound, cardiac computed tomography, exercise stress test and ankle-brachial index (ABI). All above tests were performed at the same day.

Carotid Doppler ultrasound was performed by using high-resolution Vivid 7 ultrasound (GE, USA) and high-frequency linear transducer type 9 MHz with automated measurement. Carotid Intima media thickness (cIMT) was evaluated 1 cm distal of the posterior wall of the left and right common carotid arteries and the presence of atherosclerotic plaques in common, internal and external carotid arteries was assessed. Carotid plaque was defined by the presence of focal wall thickening at least 50% greater than that of the surrounding vessel wall, or as a focal region with IMT greater than 1.5 mm, which protrude into the lumen and that is distinct from the adjacent boundary.

Cardiac Computed Tomography was performed to determine coronary calcium score (CAC) and calcium distribution. Hepatic density was performed to evaluate the presence of hepatic steatosis with Aquilion apparatus (Toshiba Medical, Tochigi, Japan) with 64 rows of detectors. The acquisition of tomographic data was represented by images of average thickness (3 mm) and low intensity (50 milliamps, 120 kV) and coupled to the electrocardiogram. Calcium score was considered present when its density in the coronary artery was above 130 Housfield units (HU) for at least 3 continuous pixels (\> 1 mm2) of the same coronary artery. Calcium score comprised the sum of individual scores of the left and right coronary arteries.

Exercise stress test was performed following under one of following protocols: Bruce, modified Bruce or Ellestad treadmill. The test was interrupted if maximum heart rate was reached or if clinical symptoms installed, including exhaustion. The exam was considered positive when there were: negative horizontal/descending deflection of ST segment measured at the J point ≥1 mm, pain suggestive of coronary artery disease, complex and sustained ventricular arrhythmias, plateau or drop in systolic blood pressure in effort and/or functional capacity lower than 5 METS.

ABI tests were performed with the patient in the supine position after resting for five minutes. Palpation of bilateral arterial pulses of pedial, posterior tibial, popliteal and brachial were performed. Measures of systolic pressures were made by a 5 MHz ultrasonography. The relationship between systolic and diastolic pressures of upper and lower limbs was used for calculating the ABI. The test was considered positive when at least one of the relationships was less than 0.9.

Personal and clinical characteristics of the patients will be described according to group using absolute and relative frequencies for qualitative characteristics and summary measures (mean, standard deviation, median, minimum and maximum) for quantitative characteristics. Distribution of the variables will be tested using Kolmogorov-Smirnov test. Comparative analyses for non-normal data will be performed using Kruskal-Wallis test and expressed as median (interquartile range). Normal data will be evaluated using analyses of variance (ANOVA) and expressed as mean ± standard deviation. To evaluate associations between categorical variables chi-square test and Fisher's Exact test will be used. Analysis of covariance (ANCOVA) adjusted for age and sex will be used to compare clinical and biochemical measures between groups (glucose, insulin, Homa-R, hs-PCR, HDL-c, triglycerides, LDL-c, HbA1c, TNF-α, leptin, 2 hours glucose and regular use of medication). Ordinal logistic regression will be used to evaluate subclinical atherosclerosis. A two-tailed P value \< 0.05 will be considered statistically significant.

Genetical, Anthropometrical and Biochemical Factors Influencing High Risk Subclinical Atherosclerosis

Subclinical Atherosclerosis: Biomarkers of Early Disease

Subclinical atherosclerosis evaluation by quantifying intima media thickness by Doppler

Subclinical atherosclerosis evaluation by Coronary Artery Calcium by CT

Subclinical atherosclerosis evaluation by brachial ankle index (BAI) by blood pressure measurement

Myocardial ischemia investigation by treadmill exercise test

Blood samples for Adiponectin, resistin, leptin, tumor necrosis factor alpha (TNF-α), lipoprotein associated phospholipase A2 (Lp-PLA2) dosing

University of Campinas, Brazil

Instituto Dante Pazzanese de Cardiologia

Adriana Bertolami

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Two Six-minute walk tests where total distance walked measured. Tests performed within 15 days of an exercise stress test.

Six-Minute walk tests at least one hour after vigorous exertion (such as exercise stress test) and at least 20 minutes in between the first and second six-minute walk tests

Six-Minute Walk Test

Scheduled gold standard exercise test, i.e. stress test, cycle ergometry with incremental workloads or oxygen consumption exercise studies

Exercise stress test

Carlos A. Jimenez, MD

The goal of this clinical research study is to compare the 6-minute walk test with the exercise stress test, in patients who may have lung surgery. Researchers want to find out if the 6-minute walk test is as good as the exercise stress test at predicting possible complications that may occur after lung surgery.

Description of the Study Tests:

The exercise stress test is commonly used for predicting possible complications that may occur after lung surgery. The 6-minute walk test is a simpler test that does not require as much equipment.

6-Minute Walk Test: If you agree to take part in this research study, you will be asked to perform two 6-minute walk tests along with your routine exercise stress test. Both 6-minute walk tests will be done within 15 Days of the already scheduled exercise stress test if your clinical condition does not change during that time period. The 6-minute walk tests should be done at least 2 hours before or 1 hour after the exercise stress test. The second 6-minute walk test may be done 20 minutes after the first one. If you had a 6-minute walk test done within 15 Days before enrolling in the study, it can be used for the study.

To perform the 6-minute walk tests, you will walk as far as possible around cones on a flat indoor course that is about 40 yards long. You will walk at your own pace and can take breaks at any time if necessary. After the 6 minutes, the study staff will tell you the total distance you have walked.

Researchers will compare the distances you walked for the two 6-minute walk tests with the results of the exercise stress test. The walk test results will not affect your treatment plan.

Other Study Procedures:

Before and after the walk tests, the following procedures will be performed. Your blood pressure will be measured. You will be asked about any shortness of breath and/or fatigue you may have.

Before, during, and for about 1 minute after the walk tests, your heart rate will be measured. A device that looks like a clothespin will be placed on your finger to wear during this time, and it will measure the amount of oxygen in your blood.

Length of Study:

You will be considered off-study after the second walk test.

If you do have lung surgery, researchers will monitor your health status by checking your medical records until you are discharged from the hospital or for 30 days after the lung surgery, whichever comes first.

This is an investigational study. Using the 6-minute walk test for this study's purpose is considered experimental. Up to 101 patients will take part in this study. All will be enrolled at M. D. Anderson.

Six-Minute Walk Test in Patients at High Risk for Complications From Lung Resection

Six-Minute Walk Test in the Evaluation of Patients at High Risk for Complications From Lung Resection

Results used to correlate the pre-operative six-minute walk test results with that of the gold standard exercise test (stress test) through analysis of gas exchange and measurement of oxygen uptake \[oxygen volume (VO2)\]. For the six-minute walk tests, recorded parameters are distance walked and pulse oximetry saturation percentage levels, and for gold standard exercise test, recorded are the gas exchange and measurement of oxygen uptake (VO2, ml/kg/min). Equivalence test performed to establish that the new test (six-minute walk) is comparable to the gold standard test (the VO2 peak) with an acceptable decreased sensitivity.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Genetical, Anthropometrical and Biochemical Factors Influencing High Risk Subclinical Atherosclerosis	NCT02487615	Primary Prevent...		25 Years - 70 Years	Instituto Dante Pazzanese de Cardiologia
Six-Minute Walk Test in Patients at High Risk for Complications From Lung Resection	NCT00450125	Lung Cancer	Six-Minute Walk... Exercise stress...	18 Years - 90 Years	M.D. Anderson Cancer Center
Genetical, Anthropometrical and Biochemical Factors Influencing High Risk Subclinical Atherosclerosis	NCT02487615	Primary Prevent...		25 Years - 70 Years	Instituto Dante Pazzanese de Cardiologia
Six-Minute Walk Test in Patients at High Risk for Complications From Lung Resection	NCT00450125	Lung Cancer	Six-Minute Walk... Exercise stress...	18 Years - 90 Years	M.D. Anderson Cancer Center

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