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

JRCT ID: jRCTs031180349

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Patients with chronic renal failure suspected of effort angina
• Date of first enrollment: 01/02/2018
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Adenosine administration during cardiac computer tomography

Outcome(s)

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

Key inclusion & exclusion criteria

• Age minimum: >= 30age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

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

Exclude criteria

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.

Related Information

• Primary Sponsor: Kodama yusuke
• Secondary ID(s): UMIN000031072