Myocardial PerfusionPerfusãoNCT02810106
Assessment of Myocardial Perfusion by Tomography and Scintigraphy in Patients With Cardiac Stress Test With Ischemia
An observational study of Myocardial Perfusion, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Myocardial Perfusion
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2017to 1 Nov 2020
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers of the population with positive exercise test for ischemia
Who may be able to join
- Patients with positive exercise test for ischemia Age> 18 years
Who cannot join
- Creatinine above 1.5 mg / dL and urea above 50 mg / dl and / or creatinine clearance <than 60ml / kg / min
- Pregnant women
- Known patients allergic to iodinated contrast or dipyridamole
- COPD and asthma
- Systolic blood pressure < 100 mmHg
- Any other aspect that the researcher considers limiting the method
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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).
- 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 0,56mg / 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 (ADW4.6 [GE]).
- Conditions
- Myocardial Perfusion
- Keywords
- Spect, Stress Test, Myocardial Perfusion CT, CT angiography
What is being measured
The primary outcome is the main question the study is designed to answer.
myocardial perfusion data
myocardial perfusion assessment by multidetector computed tomography in patients with ischemic exercise test
Measured: 2 years
Secondary outcomes (1)
Anatomical data
Evaluation of coronary anatomy by multidetector computed tomography in patients with ischemic exercise test
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study start1 Jul 2017
- Primary completion1 Feb 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial PerfusionStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergio Rodrigo Beraldo, Dr., Principal investigator, Nuclear Medicine Service of Magsul and CT scan of Corpus ImagesTiago Augusto Magalhaes, PhD, Study director, Department Resonance and Cardiac Tomography of the Heart Institute of the University of Sao PauloCarlos Eduardo Rochitte, Study chair, Department Resonance and Cardiac Tomography of the Heart Institute of the University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810106
- Sponsor's protocol ID
- PERFUSÃO
- Acronym
- Perfusão
- Status last verified
- Jun 2018
- First submitted
- 20 Jun 2016
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Myocardial Perfusion by Tomography and Scintigraphy in Patients With Cardiac Stress Test With Ischemia
- ClinicalTrials.gov ID
- NCT02810106
- Acronym / sponsor ID
- Perfusão / PERFUSÃO
- Conditions
- Myocardial Perfusion
- Keywords
- Spect, Stress Test, Myocardial Perfusion CT, CT angiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- 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 0,56mg / 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 (ADW4.6 [GE]).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers of the population with positive exercise test for ischemia
Key inclusion criteria (1 listed)
- Patients with positive exercise test for ischemia Age> 18 years
Key exclusion criteria (6 listed)
- Creatinine above 1.5 mg / dL and urea above 50 mg / dl and / or creatinine clearance <than 60ml / kg / min
- Pregnant women
- Known patients allergic to iodinated contrast or dipyridamole
- COPD and asthma
- Systolic blood pressure < 100 mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
myocardial perfusion data
Time frame: 2 years
myocardial perfusion assessment by multidetector computed tomography in patients with ischemic exercise test
1 secondary outcome
Anatomical data
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergio Rodrigo Beraldo, Dr. principal investigator
Nuclear Medicine Service of Magsul and CT scan of Corpus Images
Tiago Augusto Magalhaes, PhD study director
Department Resonance and Cardiac Tomography of the Heart Institute of the University of Sao Paulo
Carlos Eduardo Rochitte study chair
Department Resonance and Cardiac Tomography of the Heart Institute of the University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Perfusion, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
myocardial perfusion data (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.