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The Value of PET Quantitative Analysis of Coronary Physiology in Coronary Microvascular Disease

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ClinicalTrials.gov Identifier: NCT04005963
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Xiaoli Lan, Wuhan Union Hospital, China

Brief Summary:
With the aging of the population and the acceleration of urbanization process, the number of cardiovascular diseases in China continues to increase, with one in five adults suffering from cardiovascular disease. The mortality rate of cardiovascular disease in China is also on the rise, and cardiovascular disease deaths are now the leading cause of death among urban and rural residents, mainly due to ischemic heart disease (IHD). Ischemic heart disease is the damage to the heart muscle caused by changes in the coronary cycle that cause an imbalance between coronary blood flow and the needs of the heart muscle.This project obtains MBF and CFR through 13N-NH3PET cardiac blood flow perfusion rest and load imaging, and explores the diagnostic value of PET imaging to CMVD. In summary, this project will obtain myocardial blood flow (MBF) and myocardial blood flow reserve (CFR) through 13N-NH3 PET cardiac blood flow perfusion rest and load imaging, explore the diagnostic value of PET imaging for CMVD, and promote the widespread application of absolute quantification of myocardial blood flow in China.

Condition or disease Intervention/treatment
PET / CT Coronary Microvascular Disease Diagnostic Test: 13N-NH3 PET cardiac blood flow perfusion rest and load imaging

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Value of PET Quantitative Analysis of Coronary Physiology in Coronary Microvascular Disease
Actual Study Start Date : March 11, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Intervention Details:
  • Diagnostic Test: 13N-NH3 PET cardiac blood flow perfusion rest and load imaging

    Immediately after the bedside injection of 13N-NH3 370 MBq, dynamic 2D collection of heart images 10 min, scanning 1 bed; , a total of 6 min), 3min bedside injection 13N?NH3 370-540 MBq immediately after the dynamic 2D collection of heart image 10 min. Both rest and load imaging are corrected for CT attenuation.

    Image reconstruction is carried out by the method of maximum expectation of an ordered subset, the dynamic image is divided into the early phase of the first 2 min and the late phase of the last 8 min, the captured image is replayed (VIP replay) of the volume image protocol and the gated data is reconstructed.



Primary Outcome Measures :
  1. Sensitivity and specificity of 13N⁃NH3,PET/CT for initial diagnosis and staging [ Time Frame: up to 2 years ]
    For patient without any treatment, Initial diagnosis and staging results of 13N⁃NH3,PET/CT will be compared to pathology, clinical and follow-up result.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patient has symptoms such as panic, chest pain, chest tightness, etc., and morphological imaging (coronary arterial CT vascular imaging (CT angiography( CTA), coronary artery imaging) is negative, or positive but does not match the symptoms.
Criteria

Inclusion Criteria:

  • The patient has symptoms such as panic, chest pain, chest tightness, etc., and morphological imaging (coronary arterial CT vascular imaging (CT angiography( CTA), coronary artery imaging) is negative, or positive but does not match the symptoms;
  • Recently, there are electrocardiograms, echocardiograms, cardiomyotic enzymes and other test results.

Exclusion Criteria:

  • ATP or adenosine allergy;
  • systolic pressure 90mmHg (1mmHg s 0.133kPa), heart rate 40 times/min, severe arrhythmia, ii degrees above room conduction block or have a history of asthma;
  • acute myocardial infarction, acute myocarditis, mytalysis or endocarditis;
  • acute systemic diseases or infections, uncontrolled metabolic diseases, severe lung diseases, severe liver and kidney dysfunction;
  • Pregnant and lactating women.

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): NCT04005963


Contacts
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Contact: Lan Xiaoli, PhD +86-13886193262 lxl730724@hotmail.com

Locations
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China, Hubei
Xiaoli Lan Recruiting
Wuhan, Hubei, China, 430022
Contact: Xiaoli Lan    +86-13886193262    lxl730724@hotmail.com   
Sponsors and Collaborators
Wuhan Union Hospital, China
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Responsible Party: Xiaoli Lan, Director of the Department of nuclear medicine, Wuhan Union Hospital, China
ClinicalTrials.gov Identifier: NCT04005963    
Other Study ID Numbers: XLan-S894
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Microvascular Angina
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases