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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Brazil1 site
  • Corpus Imagens

    Pouso Alegre, Minas Geral, 375500000

Other trials in Brazil

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:

  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 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]).

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.

  1. myocardial perfusion data

    myocardial perfusion assessment by multidetector computed tomography in patients with ischemic exercise test

    Measured: 2 years

Secondary outcomes (1)
  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.

  1. First posted22 Jun 2016 (estimated)
  2. Study start1 Jul 2017
  3. Primary completion1 Feb 2020
  4. Study completion1 Nov 2020

Resources

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
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

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.

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