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

Coronary Artery Disease With Myocardial Infarction Clinical Trial

— Three-Cath  

Official title:

Randomized Clinical Trial to Assess the Safety of Reducing the Time of Bed Rest Within Five to Three Hours After Diagnostic Cardiac Catheterization With a 6F Sheath

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01740856
• Other study ID #: UFRGS and HCPA 100401
• Status: Completed
• Phase: N/A
• First received: October 29, 2012
• Last updated: April 10, 2016
• Start date: January 2011
• Est. completion date: February 2014

Study information

• Verified date: April 2016
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 730
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease With Myocardial Infarction
• Coronary Disease
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Other:
• Rest three hours
Intervention group (IG), will maintain bed rest supine for two hours after the digital compression. After this period prescribed, patients sit in bed with the head elevated at 45 degrees for 50 minutes and then walk within the unit hemodynamic for about 10 minutes. Afterwards patients remain sitting out of bed in hemodynamics unit, until they are five hours, then they will be discharge.
• Rest five hours
Control group (CG) maintain bed rest supine for four hours after the digital compression. After this period, the patients sit in bed with the head elevated at 45 degrees for 50 minutes and then walk into the unit hemodynamic for 10 minutes. After that patients receive discharge.

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	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.	until three days	Yes