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Mar. 18, 2019

April. 01, 2024

jRCTs031180349

Perfusion Reserve of Stenotic Coronary Artery using Cardiac Computer Tomography in Patients with Hemodialysis Suspected Coronary Artery Disease.

Perfusion Reserve of Stenotic Coronary Artery with Cardiac Computer Tomography in Patients with Hemodialysis.

Jan. 31, 2022

25

We recruited consecutively 25 patients who was determined to need invasive coronary angiography(ICA) based on clinical symptoms between May 2018 and October 2021 at Showa University Hospital, Tokyo, Japan. Two patients did not have coronary artery stenosis on coronary CT angiography(CTA), so ICA was not performed. 23 patients were undergone CTA, CT perfusion(CTP) and single photon emission computed tomography(SECT) before ICA. The exclusion criteria were as follows 1) CTA showed subtotal or total occlusion, 2) Suggestion of old myocardial infarction by myocardial delayed enhancement (MDE) CT ,3) a history of acute/old myocardial infarction, 4) a history of PCI or via coronary artery bypass grafting, 5) atrial fibrillation, 6) valvular heart dieses, 7) a history of asthma, 8) severe artifacts due to motion or breathing. After application of the exclusion criteria, 18 patients (72.2% men, age: 67.7) were recruited for this study ( 3 paitents showed total occlusion and they were suggested old myocardial infarction by MDE. 2 patitents had severe artifacts). Data collected prospectively included demographic information, existing medical diagnoses, symptom, risk factors for vascular disease,medications, and history of vascular events.

Twenty-five patients were entered into the study, and after excluding patients with obsolete myocardial infarction and poor imaging of cardiac CT, 18 patients were included in the final study.The initial target number of patients was set at 100, but due to the COVID-19 pandemic, the study was stopped at this number because the patients could not give their consent to participate in this study.

In this study, myocardial perfusion reserve (CTP) was measured by ATP loading in addition to the usual coronary CT scan, and there were no adverse events associated with ATP loading.

18 dialysis patients had high coronary artery calcium score 2353 (270-3583). Using ICA and FFR, 14 of 54 vessels was defined as obstructive CAD. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of CTA alone at the vessel level were 92.9%, 60%,44.8% and 96%. The specificity and PPV were extremely lower compared to previous reports because of high calcification. The sensitivity, specificity, PPV and NPV of integrated CTA and SPECT, CTA and CTP were 71.4%, 92.5%, 76.9% and 90% for CTA and SPECT and 85.7%, 87.5%, 70.6% and 94.6%,respectively. The area under curve (AUC) of the ROC of integrated CTA and CTP was higher than that of CTA alone (0.87 vs 0.76, p<0.05), and equivalent to that of integrated CTA and SPECT(0.87 vs 0.82, p=0.4).

Dynamic CTP helps to detect hemodynamically significant lesions in dialysis patients with high calcification. Integrated CTA and CTP leads to improve diagnostic performance in comparison with CTA alone. Integrated CTA and CTP has the same level of diagnostic performance as CTA and SPECT integration, and is useful for understanding myocardial perfusion reserve simultaneous with CTA imaging.

April. 01, 2024

No

N/A

https://jrct.mhlw.go.jp/latest-detail/jRCTs031180349

Kodama yusuke

Showa University Hospital

1-5-8 Hatanodai, Shinagawaku, Tokyo

+81-3-3784-8539

yk2857@med.showa-u.ac.jp

Kaneko Kyoichi

Showa University Hospital

1-5-8 Hatanodai, Shinagawaku, Tokyo

+81-3-3784-8539

k-kaneko@med.showa-u.ac.jp

Complete

Feb. 01, 2018

Feb. 01, 2018
100

Interventional

non-randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

diagnostic purpose

A. The male or female (no pregnancy) patients (ages: thirty to eighty five) with hemodialysis for more than one year.
B. The patients with suspected or proven coronary artery disease.
C and Written informed consent

1. Iodine allergy
2. Nephropathy with contrast media
3. Multiple myeloma or organ transplantation
4.II or III degree complete AV block
5.Severe heart disease (III or IV in NYHA classification), diagnosis or suspected moderate or severe aortic stenosis
6.Coronary artery bypass graft or cardiac surgery
7.PCI within 6 months
8 or 9. incompatible beta blocker use or drug allergy with beta blocker
10. Asthma
11. Severe COPD with Inhalants bronchodilators
12. Chief research doctor decide that the diseases which are not appropriate for this study.
13. A history of severe exposure within eighteen months: the patients was exploded more than 50 mSV or was performed more than 2 times by radioisotope study or computer tomography.
14. Acute coronary syndrome.
15. incompatible vasodilators use:
Systolic blood pressure less than 90 mmHg.
Dipyridamole or Methylate norre xanthine use
Acute coronary syndrome, recent myocardial infarction, and sinus bradycardia less than 40 bpm,
16. Body mass index more than 40.
17. Severe liver disease or heart disease which influence the absorption and metabolism of adenosine.
18. Research doctor decide that the patient is not appropriate for this study.

30age old over
85age old under

Both

Patients with chronic renal failure suspected of effort angina

Adenosine administration during cardiac computer tomography

D060050

Coronary perfusion reserve during adenosine stress cardiac CT, and prognosis after PCI (all-cause mortality, cardiac death, coronary artery stenosis, cardio-cerebro vascular disease).

Degree of coronary artery stenosis using cardiac CT angiography and cardiac catheterization, Fractional Flow Reserve using cardiac catheterization, and Myocardial perfusion reserve using adenosine stress myocardial SPECT.

Showa University Clinical Research Review Board
1-5-8 Hatanodai, Shinagawaku, Tokyo, Japan, Tokyo

+81-3-3784-8129

ura-ec@ofc.showa-u.ac.jp
Approval

Mar. 08, 2019

UMIN000031072
University Hospital Information Network (UMIN) Center

none

History of Changes

No Publication date
4 April. 01, 2024 (this page) Changes
3 Dec. 17, 2020 Detail Changes
2 Nov. 17, 2020 Detail Changes
1 Mar. 18, 2019 Detail