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Reduced in Bed Rest After Coronary Arteriography or Coronary Angioplasty

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
2 hours
4 hours
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Coronary Syndrome focused on measuring BED REST, CORONARY ANGIOPLASTY

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Hospital São Paulo - Cardiology Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

2 hours

4 hours

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Haematoma
This outcome will be measured in relation to presence or absence. The presence and will measured with a millimeter ruler taking.
Bleeding
This outcome will be measured when appear blood in a bandage or when the haemoglobin decrease more than 3g/d.
Pseudoaneurysm, Arteriovenous Fistula: Retroperitoneal hematoma, Acute Arterial Occlusion:
This outcome will be measured in relation to presence or absence by ultrasound.
Urinary retention, Paresthesia
This outcome will be measured in relation to presence or absence.

Full Information

First Posted
November 30, 2015
Last Updated
January 5, 2018
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02635906
Brief Title
Reduced in Bed Rest After Coronary Arteriography or Coronary Angioplasty
Official Title
Effectiveness of Reduced in Bed Rest After Coronary Arteriography or Coronary Angioplasty in Patients With Acute Coronary Syndrome: 4 Hours Versus 2 h.Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is a randomized clinical trial with a control group, based on the guidelines of the CONSORT 2010. It will be held in the cardiology unit of a public hospital in the city of São Paulo in patients admitted with Acute Coronary Syndrome undergoing coronary arteriography or coronary angioplasty by femoral arterial. 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 and patients at the time of withdrawal of the introducer presenting systolic blood pressure greater than 180 mmHg and diastolic than 100 mmHg. After removing the introducer the interventional group will be in a bed rest for two hours and the control group will follow the standard nursing care for four hours. Will be assessed the following indicators: bruising, bleeding, pedis pulse and popliteal, presence of blast at the puncture site after removal of the introducer, peripheral perfusion, presence of pulsatile mass, back pain, low back pain, paresthesias, urinary retention, muscle aches, use of painkillers and erythrocyte level. These indicators will be assessed prior to the procedure, immediately after removing the introducer, 6 hours after the removal of the introducer, 12 hours after removal of the introducer and 24 hours after removal of the introducer. Vascular outcomes will be considered the appearance of bruising, bleeding, pseudoaneurysm, arteriovenous fistula, retroperitoneal hematoma and acute arterial occlusion. Related to patient outcomes will be considered the complaints back pain, back pain, muscle pain, paresthesia and urinary retention. The assessment team will be composed of three nurses specialists in cardiology with a minimum of one year experience in patient care after the ATC. For this study will be presented by the principal investigator to the patient the study objectives, possible risks and complications and the study protocol, and if the patient agrees to participate in it will be delivered the Statement of Consent. The collected data regarding the patients included in the survey will be entered initially in a Microsoft Excel® 2010 software and later transferred to an electronic database software SPSS (Statistical Package for Social Sciences) version 20.0 and, then submitted to descriptive statistical analysis and comparison analysis between groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
BED REST, CORONARY ANGIOPLASTY

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2 hours
Arm Type
Experimental
Arm Description
after coronary arteriography or coronary angioplasty, will be removal the introducer and the patient will be in bed rest for two hours
Arm Title
4 hours
Arm Type
Active Comparator
Arm Description
after coronary arteriography or coronary angioplasty, will be removal the introducer and the patient will be in bed rest for four hours
Intervention Type
Other
Intervention Name(s)
2 hours
Other Intervention Name(s)
reduced bed rest
Intervention Description
BED REST FOR TWO HOURS AFTER CORONARY ARTERIOGRAPHY OR CORONARY ANGIOPLASTY
Intervention Type
Other
Intervention Name(s)
4 hours
Other Intervention Name(s)
four hours group
Intervention Description
BED REST FOR FOUR HOURS AFTER CORONARY ARTERIOGRAPHY OR CORONARY ANGIOPLASTY
Primary Outcome Measure Information:
Title
Back Pain, Lumber Pain and Muscle Pain
Description
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.
Time Frame
1 hour after the bed rest
Secondary Outcome Measure Information:
Title
Haematoma
Description
This outcome will be measured in relation to presence or absence. The presence and will measured with a millimeter ruler taking.
Time Frame
24 hours after the coronary angioplasty
Title
Bleeding
Description
This outcome will be measured when appear blood in a bandage or when the haemoglobin decrease more than 3g/d.
Time Frame
24 hours after the coronary angioplasty
Title
Pseudoaneurysm, Arteriovenous Fistula: Retroperitoneal hematoma, Acute Arterial Occlusion:
Description
This outcome will be measured in relation to presence or absence by ultrasound.
Time Frame
24 hours after the coronary angioplasty
Title
Urinary retention, Paresthesia
Description
This outcome will be measured in relation to presence or absence.
Time Frame
1 hour after the bed rest

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients admitted with Acute Coronary Syndrome undergoing coronary arteriography or coronary angioplasty by femoral arterial. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
VINICIUS B SANTOS, MASTER
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital São Paulo - Cardiology Unit
City
São Paulo
ZIP/Postal Code
04024-002
Country
Brazil

12. IPD Sharing Statement

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Reduced in Bed Rest After Coronary Arteriography or Coronary Angioplasty

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