Bolus-pCINC Study

Not Applicable

Recruiting

• Conditions: Acute myocardial inferction (ST-elevation myocardial infarction, non-ST-segment elevation myocard)

• Registration Number: JPRN-jRCTs051210170
• Lead Sponsor: Watanabe Makoto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-07
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

1 20 years old and over
2 Patients heading directly to the cardiac catheterization laboratory from the emergency outpatient department or patients with in-hospital onset
3 Patients with suspected acute myocardial infarction based on changes in electrocardiogram, elevation of myocardial enzyme, or echocardiography
4 Patients who consented to patient or legal acceptable representative in the study

Exclusion Criteria

1 Patients with shock or cardiopulmonary arrest upon arrival at the emergency department
2 Patients with impaired consciousness, orthopnoea, or needing tracheal intubation and non-invasive positive pressure ventilation (NIPPV) upon arrival at emergency department
3 Patients who received oral or intravenous sodium bicarbonate before CAG was performed
4 Patients who are allergic to contrast agents at the time of registration
5 Patients who undergoing dialysis
6 Patients who uncontrolled hyperthyroidism or hypothyroidism
7 Patients who received contrast media within 7 days of CAG or PCI
8 Patients who did not undergo PCI as the result of CAG
9 Patients who did not diagnosed with acute myocardial infarction

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CIN occur within 48 +- 12 hours<br>CIN is defined by as follows:<br>1: SCr increased by more than 0.5 mg/dL from the time of enrollment<br>2: SCr increased by more than 25% from the time of enrollment

Secondary Outcome Measures

Name	Time	Method
1 Acute renal dysfunction (SCr increase of >=1.5 times or >=0.3 mg/dL based on SCr at enrollment) occur within 48+-12 hours<br>2 CIN(SCr increased by 0.5 mg / dL or more or 25% or more based on SCr at enrollment) occur within 72 +- 12 hours<br>3 SCr increase after Catheterization / treatment at 24 +- 12 hours, at 48 +- 12 hours, at 72 +- 12 hours