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Radial Artery Occlusion After Endovascular Procedure

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ClinicalTrials.gov Identifier: NCT02762344
Recruitment Status : Unknown
Verified May 2016 by Azienda Sanitaria ULSS 13 Dolo, Mirano.
Recruitment status was:  Recruiting
First Posted : May 4, 2016
Last Update Posted : May 6, 2016
Sponsor:
Information provided by (Responsible Party):
Azienda Sanitaria ULSS 13 Dolo, Mirano

Brief Summary:
Observational cohort registry: prospective, multicenter independent evaluation of patients who undergo coronary angiography and/or PCI via radial artery. The purpose of this registry is to set the incidence of RAO according to ACT values, considered both as continuous and ordinal variable and its determinants. Coronary angiography and PCI will be performed according to usual practice.

Condition or disease Intervention/treatment
Embolism and Thrombosis of the Radial Artery Drug: heparin

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 2168 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Relationship Between Activated Clotting Time and Occlusion of Radial Artery When Used as Vascular Access for Percutaneous Endovascular Procedures.
Study Start Date : May 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Group/Cohort Intervention/treatment
ACT < 150 sec
patients who received 5000 U of heparin (in coronary angiography) or according to weight (in PCI) and having ACT value before sheath removal below 150 sec
Drug: heparin
routinary heparin administration during coronary angiography/PCI

ACT between 150 and 249 sec
patients who received 5000 U of heparin (in coronary angiography) or according to weight (in PCI) and having ACT value before sheath removal between 150 and 249 sec
Drug: heparin
routinary heparin administration during coronary angiography/PCI

ACT >= 250 sec
patients who received 5000 U of heparin (in coronary angiography) or according to weight (in PCI) and having ACT value before sheath removal above 250 sec
Drug: heparin
routinary heparin administration during coronary angiography/PCI




Primary Outcome Measures :
  1. incidence of radial occlusion [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. incidence of symptoms related to vascular access [ Time Frame: 24 hours ]
  2. incidence of significant forearm hematoma [ Time Frame: 24 hours ]
  3. incidence of pseudoaneurysm at site of vascular access [ Time Frame: 24 hours ]
  4. incidence of procedural success [ Time Frame: 24 hours ]
  5. MACCEs at 12 months [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients referred for coronary angiography and/or with planned radial access will be invited to participate.

If the radial puncture is not possible (precluding the use of radial artery as vascular access) the patient will be excluded from the registry.

Criteria

Inclusion Criteria:

  1. - Patients > 18 years
  2. - Planned transradial endovascular procedure
  3. - Written informed consent signed by the patient as approved by the Ethics Committee

Exclusion Criteria:

  1. Planned femoral access
  2. Impossible bilateral radial puncture.
  3. Anticipated impossible assess of radial patency (for example: patient transferred to other hospital immediately after the procedure)
  4. use of bivalirudin as anticoagulant during PCI
  5. use of low-molecular weight heparin (LMWH) within 12 hours from the PCI
  6. INR > 2
  7. Participation in another medical research study within 3 months of study enrollment
  8. The patient has a co-morbidity that reduces life expectancy to < 1 month
  9. Positive pregnancy assessment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02762344


Contacts
Contact: Andrea Pacchioni, MD 00390415794241 andreapacchioni@gmail.com

Locations
Italy
Ospedale Civile Recruiting
Mirano, Italy, 30035
Contact: Andrea Pacchioni, MD    00390415794241    andreapacchioni@gmail.com   
Sponsors and Collaborators
Azienda Sanitaria ULSS 13 Dolo, Mirano

Responsible Party: Azienda Sanitaria ULSS 13 Dolo, Mirano
ClinicalTrials.gov Identifier: NCT02762344     History of Changes
Other Study ID Numbers: 1
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: May 6, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Embolism and Thrombosis
Thrombosis
Embolism
Vascular Diseases
Cardiovascular Diseases
Calcium heparin
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action