Acute Coronary SyndromeNCT02635906
Reduced in Bed Rest After Coronary Arteriography or Coronary Angioplasty
A study testing 2 hours and 4 hours in people with Acute Coronary Syndrome, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- 2 hours and 4 hours
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2016to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients admitted with Acute Coronary Syndrome undergoing coronary arteriography or coronary angioplasty by femoral arterial.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- 2 hours, 4 hours
- Keywords
- BED REST, CORONARY ANGIOPLASTY
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 hoursOther
Also called reduced bed rest
BED REST FOR TWO HOURS AFTER CORONARY ARTERIOGRAPHY OR CORONARY ANGIOPLASTY
4 hoursOther
Also called four hours group
BED REST FOR FOUR HOURS AFTER CORONARY ARTERIOGRAPHY OR CORONARY ANGIOPLASTY
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: 4 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour after the bed rest
Secondary outcomes (4)
Haematoma
This outcome will be measured in relation to presence or absence. The presence and will measured with a millimeter ruler taking.
Measured: 24 hours after the coronary angioplasty
Bleeding
This outcome will be measured when appear blood in a bandage or when the haemoglobin decrease more than 3g/d.
Measured: 24 hours after the coronary angioplasty
Pseudoaneurysm, Arteriovenous Fistula: Retroperitoneal hematoma, Acute Arterial Occlusion:
This outcome will be measured in relation to presence or absence by ultrasound.
Measured: 24 hours after the coronary angioplasty
Urinary retention, Paresthesia
This outcome will be measured in relation to presence or absence.
Measured: 1 hour after the bed rest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startMar 2016
- Primary completionDec 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vinicius Batista Santos, Federal University of São Paulo
- Investigators
- VINICIUS B SANTOS, MASTER, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635906
- Sponsor's protocol ID
- 49068315.0.0000.5505
- Status last verified
- Jan 2018
- First submitted
- 30 Nov 2015
- Last updated
- 8 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02635906
- Acronym / sponsor ID
- 49068315.0.0000.5505
- Conditions
- Acute Coronary Syndrome
- Keywords
- BED REST, CORONARY ANGIOPLASTY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 21 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 hours | Experimental | Other: 2 hoursafter coronary arteriography or coronary angioplasty, will be removal the introducer and the patient will be in bed rest for two hours |
| 4 hours | Active comparator | Other: 4 hoursafter coronary arteriography or coronary angioplasty, will be removal the introducer and the patient will be in bed rest for four hours |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients admitted with Acute Coronary Syndrome undergoing coronary arteriography or coronary angioplasty by femoral arterial.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 hoursAlso: reduced bed restBED REST FOR TWO HOURS AFTER CORONARY ARTERIOGRAPHY OR CORONARY ANGIOPLASTY | Other | 2 hours |
| 4 hoursAlso: four hours groupBED REST FOR FOUR HOURS AFTER CORONARY ARTERIOGRAPHY OR CORONARY ANGIOPLASTY | Other | 4 hours |
Primary outcome
Back Pain, Lumber Pain and Muscle Pain
Time frame: 1 hour after the bed rest
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.
4 secondary outcomes
Haematoma
Time frame: 24 hours after the coronary angioplasty
Bleeding
Time frame: 24 hours after the coronary angioplasty
Pseudoaneurysm, Arteriovenous Fistula: Retroperitoneal hematoma, Acute Arterial Occlusion:
Time frame: 24 hours after the coronary angioplasty
Urinary retention, Paresthesia
Time frame: 1 hour after the bed rest
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
VINICIUS B SANTOS, MASTER study chair
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 hours and 4 hours in people with Acute Coronary Syndrome, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Back Pain, Lumber Pain and Muscle Pain (time frame: 1 hour after the bed rest). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2018.