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Assessment of Myocardial Perfusion by Tomography and Scintigraphy in Patients With Cardiac Stress Test With Ischemia (Perfusão)

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ClinicalTrials.gov Identifier: NCT02810106
Recruitment Status : Unknown
Verified June 2016 by University of Sao Paulo General Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 22, 2016
Last Update Posted : October 28, 2016
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.

Condition or disease
Myocardial Perfusion

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Assessment of Myocardial Perfusion by Tomography and Scintigraphy in Patients With Cardiac Stress Test With Ischemia
Study Start Date : July 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans




Primary Outcome Measures :
  1. myocardial perfusion data [ Time Frame: 2 years ]
    myocardial perfusion assessment by multidetector computed tomography in patients with ischemic exercise test


Secondary Outcome Measures :
  1. Anatomical data [ Time Frame: 2 years ]
    Evaluation of coronary anatomy by multidetector computed tomography in patients with ischemic exercise test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Volunteers of the population with positive exercise test for ischemia
Criteria

Inclusion Criteria:

  • Patients with positive exercise test for ischemia Age> 18 years

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810106


Contacts
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Contact: Sergio Beraldo, Dr. +5535999680911 srberaldo@hotmail.com
Contact: Tiago Magalhaes, PhD +551126615587 tiaugusto@gmail.com

Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Sergio Rodrigo Beraldo, Dr. Nuclear Medicine Service of Magsul and CT scan of Corpus Images
Study Director: Tiago Augusto Magalhaes, PhD Department Resonance and Cardiac Tomography of the Heart Institute of the University of Sao Paulo
Study Chair: Carlos Eduardo Rochitte Department Resonance and Cardiac Tomography of the Heart Institute of the University of Sao Paulo
Additional Information:

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02810106    
Other Study ID Numbers: PERFUSÃO
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Sao Paulo General Hospital:
Spect
Stress Test
Myocardial Perfusion CT
CT angiography
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes