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

NCT04005963 | Unknown

• 1 other identifier: XLan-S894
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

PET / CT; Coronary Microvascular Disease

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of 13N⁃NH3,PET/CT for initial diagnosis and staging

  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.

  up to 2 years

Interventions

13N-NH3 PET cardiac blood flow perfusion rest and load imaging DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Xiaoli Lan

Wuhan, Hubei, 430022, China

Location

MeSH Terms

Conditions

Microvascular Angina

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Xiaoli Lan, PhD

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of nuclear medicine

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 2, 2019
• Study Start: March 11, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2023
• Last Updated: February 14, 2023

Record last verified: 2023-02

Locations

CN (1)