Bolus-pCINC Study

JRCT ID: jRCTs051210170

Registered date:07/02/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acute myocardial inferction (ST-elevation myocardial infarction, non-ST-segment elevation myocard)
• Date of first enrollment: 07/02/2022
• Target sample size: 260
• Study type: Interventional
• Intervention(s): Bolus administration of sodium bicarbonate immediately before contrast medium administration

Outcome(s)

Primary Outcome

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

Secondary Outcome

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
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
3 SCr increase after Catheterization / treatment at 24 +- 12 hours, at 48 +- 12 hours, at 72 +- 12 hours

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Watanabe Makoto
• Source(s) of Monetary Support: Otsuka Pharmaceutical Factory