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CompletedNCT01740856Three-CathUpdated Apr 12, 2016

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

An interventional study of Rest three hours and Rest five hours in Coronary Artery Disease With Myocardial Infarction, sponsored by Hospital de Clinicas de Porto Alegre. Completed at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-12.

Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
730
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Coronary Artery Disease With Myocardial Infarction

Keywords

  • cardiac catheterization
  • safety
  • nursing care
  • rest
  • Patients
03

In context

Lead sponsor

Hospital de Clinicas de Porto Alegre is the lead sponsor of 456 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
730 participants (actual)

Study arms

  • Experimental
    Rest three hours

    Rest three hours

    Other: Rest three hours

  • Experimental
    Rest five hours

    Rest five hours

    Other: Rest five hours

Interventions

  • OtherRest 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.

  • OtherRest 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: until three days

07

Study locations

1 site
  • Hospital de Clinicas de Porto Alegre
    Porto Alegre, Rio Grande do Sul 90035003, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01740856
Responsible party
Eneida Rejane Rabelo da Silva (Professor, ScD, Hospital de Clinicas de Porto Alegre) — Principal investigator
First posted
Dec 4, 2012
Start date
Jan 2011
Primary completion
Dec 2013
Completion
Feb 2014
Last update
Apr 12, 2016

Study contacts

Eneida R Rabelo da Silva, Professor
principal investigator · Hospital de Clinicas de Porto Alegre - Graduate Programa from Nursing School at Federal University of Rio Grande do Sul
Roselene Matte, RN, MSc
principal investigator · Hospital de Clinicas de Porto Alegre

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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