NCT02635906

Brief Summary

This is a randomized clinical trial with a control group, based on the guidelines of the CONSORT 2010. The interventional group will be in a bed rest for two hours after introducer removal in patients submitted a coronary arteriography or coronary angioplasty and the control group will follow the standard nursing care for four hours.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 21, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

January 8, 2018

Status Verified

January 1, 2018

Enrollment Period

1.8 years

First QC Date

November 30, 2015

Last Update Submit

January 5, 2018

Conditions

Acute Coronary Syndrome

Keywords

BED RESTCORONARY ANGIOPLASTY

Outcome Measures

Primary Outcomes (1)

  • Back Pain, Lumber Pain and Muscle Pain

    This outcome will be measured in relation to presence or absence. The presence and will Assess by means of a visual analog scale of 0 to 10, whereas the smallest value as no pain and the largest value as unbearable pain.

    1 hour after the bed rest

Secondary Outcomes (4)

  • Haematoma

    24 hours after the coronary angioplasty

  • Bleeding

    24 hours after the coronary angioplasty

  • Pseudoaneurysm, Arteriovenous Fistula: Retroperitoneal hematoma, Acute Arterial Occlusion:

    24 hours after the coronary angioplasty

  • Urinary retention, Paresthesia

    1 hour after the bed rest

Study Arms (2)

2 hours

EXPERIMENTAL

after coronary arteriography or coronary angioplasty, will be removal the introducer and the patient will be in bed rest for two hours

Other: 2 hours

4 hours

ACTIVE COMPARATOR

after coronary arteriography or coronary angioplasty, will be removal the introducer and the patient will be in bed rest for four hours

Other: 4 hours

Interventions

2 hoursOTHER

BED REST FOR TWO HOURS AFTER CORONARY ARTERIOGRAPHY OR CORONARY ANGIOPLASTY

Also known as: reduced bed rest
2 hours
4 hoursOTHER

BED REST FOR FOUR HOURS AFTER CORONARY ARTERIOGRAPHY OR CORONARY ANGIOPLASTY

Also known as: four hours group
4 hours

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients admitted with Acute Coronary Syndrome undergoing coronary arteriography or coronary angioplasty by femoral arterial.

You may not qualify if:

  • patients with hemodynamic instability will be excluded before and after the ATC,
  • patients using oral anticoagulants presenting INR greater than 2;
  • patients using inhibitors IIB / IIIa;
  • patients with history of blood dyscrasias;
  • patients undergoing invasive procedure again less than 24 hours;
  • patients with previous diagnosis of arterial insufficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital São Paulo - Cardiology Unit

São Paulo, 04024-002, Brazil

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Officials

  • VINICIUS B SANTOS, MASTER

    Federal University of São Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nursing Coordinator

Study Record Dates

First Submitted

November 30, 2015

First Posted

December 21, 2015

Study Start

March 1, 2016

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

January 8, 2018

Record last verified: 2018-01

Locations

BR(1)