Reduced in Bed Rest After Coronary Arteriography or Coronary Angioplasty

Status Completed

Clinical 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 for four hours.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02635906
Study type	Interventional
Source	Federal University of São Paulo
Contact
Status	Completed
Phase	N/A
Start date	March 2016
Completion date	January 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06013813` - Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI	N/A
Recruiting	`NCT05846893` - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease	N/A
Recruiting	`NCT05412927` - AngelMed Guardian® System PMA Post Approval Study
Completed	`NCT02750579` - Early or Delayed Revascularization for Intermediate and High-risk Non ST-elevation Acute Coronary Syndromes?	N/A
Completed	`NCT04102410` - Assessing Force-velocity Profile: an Innovative Approach to Optimize Cardiac Rehabilitation in Coronary Patients	N/A
Enrolling by invitation	`NCT03342131` - Serum Concentration of Wnt2 and Wnt4 in Patients With Acute Coronary Syndrome	N/A
Recruiting	`NCT01218776` - International Survey of Acute Coronary Syndromes in Transitional Countries
Enrolling by invitation	`NCT04676100` - International CR Registry
Completed	`NCT03590535` - 5th Generation cTnT in ED ACS
Recruiting	`NCT05437900` - INSIGHTFUL-FFR Clinical Trial	Phase 4
Completed	`NCT05551429` - Factors Related to Participation in Cardiac Rehabilitation in Patients With Acute Coronary Syndrome
Terminated	`NCT04316481` - IDE-ALERTS Continued Access Study	N/A
Active, not recruiting	`NCT04475380` - Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
Not yet recruiting	`NCT04852146` - Electronic Feedback for Data Restitution and Valorization to the Emergency Teams in Aquitaine.
Active, not recruiting	`NCT02892903` - In the Management of Coronary Artery Disease, Does Routine Pressure Wire Assessment at the Time of Coronary Angiography Affect Management Strategy, Hospital Costs and Outcomes?	N/A
Completed	`NCT04077229` - Piloting Text Messages to Promote Positive Affect and Physical Activity	N/A
Not yet recruiting	`NCT02871622` - BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM	N/A
Completed	`NCT02944123` - Half Dose of Prasugrel and Ticagrelor in Acute Coronary Syndrome (HOPE-TAILOR)	Phase 3
Active, not recruiting	`NCT02922140` - The Impact of Pharmaceutical Care Practice on Patients in Cardiac Rehabilitation Unit	N/A
Completed	`NCT02673437` - Rivaroxaban ACS Specialist Cohort Event Monitoring Study