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AzTrials

PET / CTNCT04005963

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

An observational study of PET / CT and Coronary Microvascular Disease, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
PET / CT, Coronary Microvascular Disease
What is being tested?
13N-NH3 PET cardiac blood flow perfusion rest and load imaging
Type of treatment
Injection or infusion
How many people
150 participants
Where
1 siteChina
Study dates
11 Mar 2019to 31 Dec 2023
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 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Xiaoli Lan

    Wuhan, Hubei, 430022

Other trials in China

About this study

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.

Read the detailed description

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.

The most common cause of which is coronary arterial stenosis and blocking caused by coronary atherosclerosis, accounting for about 90% of ischemic heart disease, referred to as coronary heart disease. Coronary artery microvascular lesions .coronary microvascular disease. CMVD) is a type of coronary atherosclerosis heart disease (coronary heart disease) that refers to the clinical syndrome of labor-induced angina or myocardial ischemia caused by abnormal structure and/or dysfunction of the small and small arteries before the coronary disease under the influence of a variety of pathogenic factors. The mechanisms of myocardial ischemia include coronary atherosclerosis disease, vascular spasm disease and coronary artery microvascular dysfunction, which may overlap between three causes.

Future breakthroughs in the treatment of coronary heart disease depend on the understanding and intervention of CMVD. The incidence of CMVD is high, and studies show that more than 60% of patients with obstructive coronary heart disease co-exist CMVD coexist with CMVD, up to 67. 4% of non-obstructive coronary patients have CMVD, and the proportion of non-obstructive coronary heart disease in stable angina patients increased year by year. Studies in 11,223 patients with stable angina showed that, like obstructive coronary heart disease, non-obstructive coronary heart disease also increased the incidence of major cardiovascular adverse events in male and female patients.

Therefore, the early detection, clear diagnosis and timely treatment of CMVD is essential. At present, there are limited methods for evaluating CMVD in clinical conventional applications, including PET, transthoracic Doppler echocardiography, SPECT, CMR Traumatic techniques include selective coronary artery imaging, coronary artery doppler blood flow conduction technology, temperature dilution to measure coronary artery blood flow and CFR, microvascular resistance index. PET's greatest advantage is that it can make a variety of precise physical corrections and measure the absolute value of myocardial blood flow in rest and congestion, completely evaluate the function of the whole heart and local heart muscle, and have a higher spatial resolution than traditional SPECT; Cannot be measured repeatedly and has shortcomings such as radiation. TTDE has the advantages of non-invasive, time-saving, bedside examination, low cost and repeatable measurement, but it has high reliability only when evaluating the microvascular function of the left front drop, and the ultrasound physician must have operational experience. SPECT has high diagnostic sensitivity and negative predictive value, but it is not possible to quantify CFR, and has low spatial resolution and radiation. CMR space resolution is high, no radiation, no signal attenuation, can simultaneously detect cardiomyopathy function, tissue morphology, cardiomyopathy, cardiomyocyte and fibrosis, has gradually become a noninvasive evaluation of cardiomyopathy "gold standard", but the contrast agent in patients with renal insufficiency is prone to adverse reactions, and there are many taboo evidence. Coronary artery angiography can only show blood vessels that account for 5% of the entire coronary artery tree, with a diameter greater than l00 m, and 95% of the small blood vessels that cannot be displayed. The Coronary artery doppler blood flow guide wire measurement CFR is considered to be the "gold standard" for invasive examinations, the disadvantage of being traumatic and having trouble with operation. The temperature dilution method has a good correlation with the CFR measured by Doppler in the coronary arteries, but its measurement value will be influenced by pressure, temperature, saline injection dose and speed, salt water and blood mixing unevenly, and so on. Microvascular resistance index can specifically evaluate the microvascular function at the far end of narrow lesions, but the relationship between the measured value and cardiovascular events is not yet clear. Coronary artery microvascular function is usually assessed by detecting coronary artery blood flow reserve (coronary flow reserve, CFR) function. PET is considered the "gold standard" for noninvasive evaluation of CFR and provides absolute quantification of myocardial blood flow (MBF) and CFR. Studies have shown that CFR 2 is an independent predictor of adverse cardiovascular events, and microvascular lesions increase the risk of cardiovascular adverse events in patients after myocardial infarction. There is currently a lack of prospective clinical studies to diagnose CMVD by using PET to evaluate CFR.

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.

Being tested
13N-NH3 PET cardiac blood flow perfusion rest and load imaging
Medical subject headings
Microvascular Angina

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 13N-NH3 PET cardiac blood flow perfusion rest and load imagingDiagnostic 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 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 posted2 Jul 2019
  2. Study start11 Mar 2019
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2023 (estimated)

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
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04005963
Sponsor's protocol ID
XLan-S894
Status last verified
Feb 2023
First submitted
28 Jun 2019
Last updated
14 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of PET / CT and Coronary Microvascular Disease, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Feb 2023. 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 China. 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?

Results are not available in the source record.

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?

Sensitivity and specificity of 13N⁃NH3,PET/CT for initial diagnosis and staging (time frame: up to 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 14 Feb 2023.

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