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

NCT02810106 | Completed DMC

• 1 other identifier: PERFUSÃO
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Perfusion

Keywords

Spect; Stress Test; Myocardial Perfusion CT; CT angiography

Outcome Measures

Primary Outcomes (1)

• myocardial perfusion data

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

  2 years

Secondary Outcomes (1)

• Anatomical data

  2 years

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Volunteers of the population with positive exercise test for ischemia

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Corpus Imagens

Pouso Alegre, Minas Geral, 375500000, Brazil

Location

Study Officials

• Sergio Rodrigo Beraldo, Dr.

  Nuclear Medicine Service of Magsul and CT scan of Corpus Images

  PRINCIPAL INVESTIGATOR

• Tiago Augusto Magalhaes, PhD

  Department Resonance and Cardiac Tomography of the Heart Institute of the University of Sao Paulo

  STUDY DIRECTOR

• Carlos Eduardo Rochitte

  Department Resonance and Cardiac Tomography of the Heart Institute of the University of Sao Paulo

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 22, 2016
• Study Start: July 1, 2017
• Primary Completion: February 1, 2020
• Study Completion: November 1, 2020
• Last Updated: November 5, 2020

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)