Clinical Trial to Assess the Safety of Reducing the Time of Bed Rest After Cardiac Catheterization

Not Applicable

Completed

• Conditions: Coronary Artery Disease With Myocardial Infarction
• Interventions: Other: Rest three hours; Other: Rest five hours

• Registration Number: NCT01740856
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

Reducing the rest time after diagnostic cardiac catheterization for three hours does not increase the complications concerning to the procedure, compared to the rest of five hours.

Detailed Description

Reducing the rest time after diagnostic cardiac catheterization for three hours does not increase the complications concerning to the procedure, compared to the rest of five hours. The aim of this study is to compare through a randomized clinical trial to reduce the rest time in bed for five hours after elective diagnostic cardiac catheterization, with a 6F sheath with a transfemoral approach, for a period of three hours of the occurrence of bleeding, hematoma, pseudoaneurysm and a vasovagal reaction.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-10-29
• Study First Submitted QC: 2012-11-30
• Study First Posted: 2012-12-04
• Primary Completion: 2013-12
• Study Completion: 2014-02
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-10
• Last Update Posted: 2016-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 730

Inclusion Criteria

• age equal too or above 18 years
• patients undergoing elective diagnostic cardiac catheterization on an outpatient basis and
• who agree to participate by reading and signing the informed consent form.

Exclusion Criteria

• patients with restriction ambulation;
• users of coumarin anticoagulants;
• IMC greater than 35 kg/m2;
• patients with hypertension (systolic PA > 180 mmHg and diastolic PA > 110 mmHg) at the end of the procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rest three hours	Rest three hours	Rest three hours
Rest five hours	Rest five hours	Rest five hours

Primary Outcome Measures

Name	Time	Method
Safety	until three days	Bleeding: seen after the femoral compression after walking and after sitting down ;Hematoma, pseudoaneurysm and bruise: at the site of arterial puncture;vaso-vagal reaction. All of these will be monitoring by telephone contact at 24h, 48h and 72 hours.

Trial Locations

Locations (1)

Hospital de Clinicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil