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Optical coherence tomography with hetastarch versus conventional contrast agents during percutaneous coronary intervention in patients at high risk of contrast induce acute kidney injury: a single-center, prospective, randomized controlled study

Optical coherence tomography with hetastarch versus conventional contrast agents during percutaneous coronary intervention in patients at high risk of contrast induce acute kidney injury: a single-center, prospective, randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063080
Enrollment
Unknown
Registered
2022-08-30
Start date
2022-08-31
Completion date
Unknown
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronary heart disease

Interventions

Experimental group:Hetastarch was used as an medium during OCT to guide PCI during OCT
Control group:Contrast was used as an medium during OCT to guide PCI during OCT

Sponsors

The PLA Northern Theater Command General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Subjects >= 18 years old; 2. Subjects must have evidence of myocardial ischemia suitable for elective PCI; 3. Subjects must meet at least three or more items to be identified as CI-AKI high-risk patients: (1) Preoperative estimated glomerular filtration rate eGFR=(30-60) ml/min/1.73m^2; (2) Over 70 years old; (3) Diabetic patients; (4) Application of intra-aortic balloon counterpulsation (IABP); (5) Previous cardiogenic shock; previous cardiac arrest; (6) Anemia (adult male Hb = 70%, or multi-vessel disease, non-target vessel stenosis 1 month; 5. Voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. The subject's age is less than 18 years old; 2. Subjects have no evidence of myocardial ischemia undergoing elective PCI; 3. Subjects do not meet the definition of CI-AKI high-risk patients; 4. Preoperative estimated glomerular filtration rate eGFR = 70%, no revascularization; 9. Patients who only use drug balloons; 10. Patients with severe heart failure: patients with ejection fraction (EF) < 35% or NYHA heart function class IV; 11. Hemodynamic instability: KILLIP III, IV patients; 12. Severe anemia: hemoglobin < 60 g/L; 13. Platelet count < 100 x 10^9/L; 14. Patients with intracranial hemorrhage (within 1 month) or major organ hemorrhage or recent surgery for gastrointestinal tumors; 15. Patients with oliguria or anuria (oliguria: urine output less than 400 ml in 24 hours; anuria: urine output less than 100ml in 24 hours); 16. Patients receiving dialysis treatment; 17. Patients who are allergic to hydroxyethyl starch or contrast agents; 18. Pregnant patients; 19. The patient has no willingness for PCI treatment; 20. Combined with other contraindications for coronary intervention; 21. Any situation where informed consent cannot be obtained or the researcher considers it inappropriate to participate in this study; 22. Participate in other ongoing clinical research (except for patients who obtain the primary clinical endpoint).

Design outcomes

Primary

MeasureTime frame
Serum creatinine;

Countries

China

Contacts

Public ContactWang Xiaozeng

The PLA Northern Theater Command General Hospital

wxiaozeng@163.com+86 13309885980

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026