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ZEro contrast dye used for percutaneous Revascularization Outcome study

ZEro contrast percutaneous Revascularization Outcome A randomized pilot trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/044028
Enrollment
100
Registered
2022-07-14
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Health Condition 1: I229- Subsequent ST elevation (STEMI) myocardial infarction of unspecified site

Interventions

Intervention1: Angioplasty: Not using contrast during the angioplasty procedure

Sponsors

The madras medical mission
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All consecutive patients, at high risk of developing CI-AKI (Mehran’s score >10) and undergo PCI will be randomized .

Exclusion criteria

Exclusion criteria: ST elevation myocardial infarction patients who will undergo primary PCI Chronic total occlusion Not willing to give consent for the study

Design outcomes

Primary

MeasureTime frame
The composite cardio-renal outcome at one-year post PCI will be compared between the zero-contrast PCI and standard of care PCI groups using Kaplan-meier survival analysis. Log rank test will be used to analyze the statistical significance. Kaplan-meier survival analysis will be done separately for ITT and per protocol populations. The individual events also will be compared using log rank test. Timepoint: One year

Secondary

MeasureTime frame
Defined as increase in serum creatinine by 0.3 mg/dl within 48 hours or Increase in serum creatinine to 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days or urine volume less than 0.5 ml/kg/hour for 6 hours.7Timepoint: BASELINE one month and one year

Countries

India

Contacts

Public ContactDr Nandhakumar Vasudevan

The madras medical mission

nandha.intervention@gmail.com9715278871

Outcome results

None listed

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