Ignite Creation Date:
2024-05-06 @ 8:45 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02810106
Status:
COMPLETED
Last Update Posted:
2020-11-05
First Post:
2016-06-20
Brief Title:
Assessment of Myocardial Perfusion by Tomography and Scintigraphy in Patients With Cardiac Stress Test With Ischemia
Sponsor:
University of Sao Paulo General Hospital
Organization:
University of Sao Paulo General Hospital
Study Overview
Official Title:
Assessment of Myocardial Perfusion by Tomography and Scintigraphy in Patients With Cardiac Stress Test With Ischemia
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Perfusão
Brief Summary:
Cardiovascular diseases are important cause of death and of these have highlighted the Coronary Artery Disease CAD and its various clinical manifestations The chest pain suggestive of ischemic heart disease is frequent complaint in medical consultations and hospitalizations Complementary tests and images exams for risk stratification as Cardiac Stress Test ET the Myocardial Perfusion scintigraphy of SPECT are established for risk stratification and assessment workup in suspected ischemic heart disease Coronary tomography angiography CTA has emerged as a robust method for non-invasive assessment of CAD showing data diagnostics that directly correlate with invasive coronary angiography Recently the Myocardial Perfusion by Tomography Computed CTP has emerged as a new technique to measure the flow limitation for coronary microcirculation In clinical practice the exercise testing with electrocardiogram changes compatible with myocardial ischemia can lead to other examinations for elucidation of ischemic etiology the most usual myocardial scintigraphy However a SPECT without evidence of ischemia does not explain ischemic electrocardiographic changes triggered by physical stress although it is a good marker prognostic A CTP is a emerging tool in the evaluation of myocardial ischemia Recent studies point to a good accuracy of the method compared to nuclear medicine To test this hypothesis this study aims to evaluate whether the CTP has a better diagnostic performance in detecting of obstructive or not obstructive CAD compared to the SPECT in the population of patients with exercise stress testing compatible with myocardial ischemia and the computed tomography angiography CTA as the reference method In addition data from the exercise test functional capacity hemodynamics electrocardiogram changes will be compared to findings of CTA and CTP
Detailed Description:
Patients will be recruited in private Nuclear Medicine Service to perform myocardial perfusion scintigraphy with physical stress SPECT-ET that present the exercise test less than 60 days positive for ischemia as electrocardiographic criteria enshrined in current guidelines of the Brazilian Society of Cardiology These patients will be invited to participate in the study guided and included after signing an informed consent form
Patients included in the study will be submitted to 2 images exams protocols
1 Myocardial perfusion scintigraphy with physical stress SPECT-ET
Patients referred from other services with exercise testing positive ischemic response will be instructed to discontinue the drugs in use that may affect the ET as negative and coronary vasodilator action inotropic drugs They will undergo perfusion study myocardial scintigraphy SPECT at rest and physical stress 1 day protocol starting with Sestamibi Tn in injection 99 mtc at a dose of 10 millicurie and capture resting scintigraphic images in Gamma Camera GE millenium Then they will undergo phase of physical stress with maximum ET exercise until exhaustion or intense physical exertion on the Borg Scale modified under Bruce protocol At the peak of the effort will be injected into the radio tracer TC-99m Sestamibi at a dose of 30 mCi milli Curie and then quantified in Gamma Camera GE millenium scintigraphic images after physical stress
During the exercise test electrocardiographic variables will be evaluated as magnitude and morphology of ST segment changes precocity and duration of these changes hemodynamic variables such as behavior of the pressure curve and clinical variables
The perfusion myocardial study by Gated SPECT single-photon emission computed tomography will be analyzed qualitatively by 2 experienced examiners and semi-quantitatively using severity scores widely validated in the literature SSS - Summed Stress Score SRS - Summed Rest Score SDS - summed Difference Score
2 Myocardial Perfusion and Angiography by Computed Tomography Patients will undergo myocardial perfusion computed tomography with multiple detectors after dipyridamole as established protocol anteriores10 studies followed by coronary angiography at rest CTA in tomography with 128 multi-detector channels Optima 660 CT GE
Patients will be instructed to perform absolute fast 4 hours for the exam and fasting for 24 foods with caffeine and medications containing xanthine derivatives It will be obtained venous access caliber in the right upper limb and cardiac monitoring continues They will be assessed and recorded weight height blood pressure BP heart rate HR at rest and respiratory rate before during and after the examination tomography
The evaluation of the pharmacological stress PMTC be performed after dipyridamole administration in a dose of 056mg kg for 4 minutes images according to protocol previously validated in this study instituição10 immediately after injection of iodinated contrast After 2 minutes of dipyridamole administration of completion will be performed Approximately 60ml of nonionic iodinated intravenous contrast medium is administered by an automated gun to a 3ml s
After the stress phase and the pharmacological reversal with aminophylline 240 mg will be held the control of heart rate metoprolol 5 mg IV every 5 minutes max 20mg with the objective of reaching a HR 60 for carrying out the acquisition of coronary angiography The acquisition parameters for CTA resting phase will be individualized according to the weight sex and heart rate of each patient in order to maintain a total dose of not more radiation 15mSv therefore a safe dose of radiation with the image quality maintenance three-dimensional reconstructions and perfusion algorithm will be performed with the use of dedicated workstation ADW46 GE
Patients included in the study will be submitted to 2 images exams protocols
1 Myocardial perfusion scintigraphy with physical stress SPECT-ET
Patients referred from other services with exercise testing positive ischemic response will be instructed to discontinue the drugs in use that may affect the ET as negative and coronary vasodilator action inotropic drugs They will undergo perfusion study myocardial scintigraphy SPECT at rest and physical stress 1 day protocol starting with Sestamibi Tn in injection 99 mtc at a dose of 10 millicurie and capture resting scintigraphic images in Gamma Camera GE millenium Then they will undergo phase of physical stress with maximum ET exercise until exhaustion or intense physical exertion on the Borg Scale modified under Bruce protocol At the peak of the effort will be injected into the radio tracer TC-99m Sestamibi at a dose of 30 mCi milli Curie and then quantified in Gamma Camera GE millenium scintigraphic images after physical stress
During the exercise test electrocardiographic variables will be evaluated as magnitude and morphology of ST segment changes precocity and duration of these changes hemodynamic variables such as behavior of the pressure curve and clinical variables
The perfusion myocardial study by Gated SPECT single-photon emission computed tomography will be analyzed qualitatively by 2 experienced examiners and semi-quantitatively using severity scores widely validated in the literature SSS - Summed Stress Score SRS - Summed Rest Score SDS - summed Difference Score
2 Myocardial Perfusion and Angiography by Computed Tomography Patients will undergo myocardial perfusion computed tomography with multiple detectors after dipyridamole as established protocol anteriores10 studies followed by coronary angiography at rest CTA in tomography with 128 multi-detector channels Optima 660 CT GE
Patients will be instructed to perform absolute fast 4 hours for the exam and fasting for 24 foods with caffeine and medications containing xanthine derivatives It will be obtained venous access caliber in the right upper limb and cardiac monitoring continues They will be assessed and recorded weight height blood pressure BP heart rate HR at rest and respiratory rate before during and after the examination tomography
The evaluation of the pharmacological stress PMTC be performed after dipyridamole administration in a dose of 056mg kg for 4 minutes images according to protocol previously validated in this study instituição10 immediately after injection of iodinated contrast After 2 minutes of dipyridamole administration of completion will be performed Approximately 60ml of nonionic iodinated intravenous contrast medium is administered by an automated gun to a 3ml s
After the stress phase and the pharmacological reversal with aminophylline 240 mg will be held the control of heart rate metoprolol 5 mg IV every 5 minutes max 20mg with the objective of reaching a HR 60 for carrying out the acquisition of coronary angiography The acquisition parameters for CTA resting phase will be individualized according to the weight sex and heart rate of each patient in order to maintain a total dose of not more radiation 15mSv therefore a safe dose of radiation with the image quality maintenance three-dimensional reconstructions and perfusion algorithm will be performed with the use of dedicated workstation ADW46 GE
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None