Correlation Between Endothelial Function and Trans Radial-procedural Events

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02017028
Recruitment Status : Completed
First Posted : December 20, 2013
Last Update Posted : May 18, 2017
Information provided by (Responsible Party):
Sheba Medical Center

Brief Summary:
The aim of this study is to investigate the relation between the previous presence of endothelial dysfunction and the development of radial artery vasospasm during the trans-radial coronary evaluation.

Condition or disease
Injury; Blood Vessel, Wrist, Radial Artery

Detailed Description:
All patient will undergo pre procedural endoPAT assessment for endothelial dysfunction

Study Type : Observational [Patient Registry]
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Correlation Between Endothelial Function and Trans Radial-procedural Events
Study Start Date : January 2015
Actual Primary Completion Date : December 30, 2016
Actual Study Completion Date : December 30, 2016

Primary Outcome Measures :
  1. To assess relation between the presence of previous endothelial dysfunction and radial artery vasospasm [ Time Frame: 1 month ]

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients planned for elective trans-radial cath

Inclusion Criteria:

Patients without angiographic proof of coronary disease, with scheduled elective coronary angiographic evaluation by radial approach.

Exclusion Criteria:

Impossibility to perform radial approach; abnormal Barbeau test result (type C and D); previous important trauma of the upper limbs; presence of fistule for renal dialysis; lymphedema; acute myocardial infarction, severe valvular heart disease; patients with NYHA class III and IV heart failure; malignancy; active myocarditis; HIV infection or immunodeficiency state; chronic viral infection; acute systemic infection requiring antibiotics; systemic inflammatory disease; Raynaud's syndrome; refusal to sign the informed consent form. All participants must give a written informed consent

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 identifier (NCT number): NCT02017028

Sheba Medical center
Ramat Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Principal Investigator: Amit Segev, MD Sheba MC

Responsible Party: Sheba Medical Center Identifier: NCT02017028     History of Changes
Other Study ID Numbers: SHEBA-13-0824-IB-CTIL
First Posted: December 20, 2013    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2016

Additional relevant MeSH terms:
Vascular System Injuries
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries