NCT02762344

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,168

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 6, 2016

Status Verified

May 1, 2016

Enrollment Period

1 year

First QC Date

May 3, 2016

Last Update Submit

May 5, 2016

Conditions

Embolism and Thrombosis of the Radial Artery

Outcome Measures

Primary Outcomes (1)

  • incidence of radial occlusion

    24 hours

Secondary Outcomes (5)

  • incidence of symptoms related to vascular access

    24 hours

  • incidence of significant forearm hematoma

    24 hours

  • incidence of pseudoaneurysm at site of vascular access

    24 hours

  • incidence of procedural success

    24 hours

  • MACCEs at 12 months

    12 months

Study Arms (3)

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

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

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

Interventions

heparinDRUG

routinary heparin administration during coronary angiography/PCI

ACT < 150 secACT >= 250 secACT between 150 and 249 sec

Eligibility Criteria

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

You may qualify if:

  • \- Patients \> 18 years
  • \- Planned transradial endovascular procedure
  • \- Written informed consent signed by the patient as approved by the Ethics Committee

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Civile

Mirano, 30035, Italy

RECRUITING

Related Publications (2)

  • Pacchioni A, Bellamoli M, Mugnolo A, Ferro J, Pesarini G, Turri R, Ribichini F, Sacca S, Versaci F, Reimers B. Predictors of patent and occlusive hemostasis after transradial coronary procedures. Catheter Cardiovasc Interv. 2021 Jun 1;97(7):1369-1376. doi: 10.1002/ccd.29066. Epub 2020 Jun 17.

    PMID: 32761864DERIVED

  • Pacchioni A, Ferro J, Pesarini G, Mantovani R, Mugnolo A, Bellamoli M, Penzo C, Marchese G, Benedetto D, Turri R, Fede A, Benfari G, Sacca S, Ribichini F, Versaci F, Reimers B. The Activated Clotting Time Paradox: Relationship Between Activated Clotting Time and Occlusion of the Radial Artery When Used as Vascular Access for Percutaneous Coronary Procedures. Circ Cardiovasc Interv. 2019 Sep;12(9):e008045. doi: 10.1161/CIRCINTERVENTIONS.119.008045. Epub 2019 Sep 13.

    PMID: 31514524DERIVED

MeSH Terms

Conditions

Embolism

Interventions

Heparin

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Central Study Contacts

Andrea Pacchioni, MD

CONTACT

00390415794241andreapacchioni@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2016

First Posted

May 4, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2018

Last Updated

May 6, 2016

Record last verified: 2016-05

Locations

IT(1)