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临床试验/CTRI/2021/09/036375
CTRI/2021/09/036375招募中未知

A Prospective, Multicentric, Registry to Evaluate the Impact of FFR and OCT on the Outcomes of PCI in Diabetic Patients - iFOCUS - iFOCUS Registry

Ananthapuri Hospitals and Research Institute0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
招募中
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

入选标准

  • 1. Diabetes inclusion criteria
  • a. Previously diagnosed and currently on diabetes medication
  • b. Patient having any one of the below as per American Diabetes Association criteria (HbA1c ââ?°Â¥6.5% or Fasting plasma glucose ââ?°Â¥126 mg/dL (7.0 mmol/L) or 2-hour glucose ââ?°Â¥200 mg/dL (11.1mmol/L))
  • 2. Patients of either gender, aged ââ?°Â¥ 18 years
  • 3. DM patients with single or multivessel lesions in native vessels, undergoing PCI and suitable for invasive cardiovascular diagnostic procedures, FFR and OCT
  • 4. Patients with Unstable Angina, stable ischemic heart disease, or NSTEMI
  • 5. Willing to provide inform consent to share the data

排除标准

  • 1. Patients unwilling to sign the informed consent
  • 2. Hemodynamic instability or cardiogenic shock patients
  • 3. Patients who have a life expectancy of less than 12 months
  • 4. Contraindication for dual antiplatelet therapy (DAPT)
  • 5. Patients with Chronic Total Occlusion lesions, Aorto-Ostial lesions
  • 6. Prior CABG patients
  • 7. Lesions with in-stent restenosis
  • 8. Left Main disease patients
  • 9. Patients with GFR < 30 ml/min
  • 10. Patients with KILLIP class III or IV
  • 11. Patients with STEMI
  • 12. Distal coronary lesions where OCT or FFR study may be difficult to perform
  • 13. Patients as per the discretion of treating physician, lesions where FFR and/or OCT cannot be performed due to technical reasons

研究者

发起方
Ananthapuri Hospitals and Research Institute

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