Radial Artery OcclusionHANGARNCT01853943
Hand Grip Test and Transradial Coronary Procedures
An observational study of Radial Artery Occlusion, run by Ospedale Sandro Pertini, Roma at 1 site in Italy.
Trial summary
Transradial coronary procedures are gaining in popularity worldwide. A possible complication of transradial approach is the occlusion of the radial artery that in most cases is asymptomatic. However the investigators do not know if the radial artery occlusion may impact over the muscle force of the hand or fingers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radial Artery Occlusion
- How many people
- 107 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2012to Dec 2014
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stable patients who undergo elective percutaneous transradial coronary procedures
Who may be able to join
- Stable patients who undergo elective percutaneous transradial coronary procedures
Who cannot join
- hemodynamic instability,
- acute coronary syndromes,
- haemodialysis patients with an arteriovenous fistula,
- sheath diameter > 6 French,
- age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hand Grip Test After Transradial Percutaneous Coronary Procedures
Transradial coronary procedures are gaining in popularity worldwide. A possible complication of transradial approach is the occlusion of the radial artery that in most cases is asymptomatic. However the investigators do not know if the radial artery occlusion may impact over the muscle force of the hand or fingers.
To evaluate if transradial approach for percutaneous coronary procedures may affect muscle force of the hand, thumb and index finger the investigators use a standardized hand-grip manometer and a pinch gauge before the transradial procedure, the day after the procedures and after few months.
- Conditions
- Radial Artery Occlusion
- Keywords
- Transradial approach, radial occlusion, hand grip, coronary angiography
- Medical subject headings
- Arterial Occlusive Diseases, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patent radial artery | Patient with patent radial artery after the percutaneous coronary procedure | |
| Occluded radial artery | Patients with occluded radial artery after the procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand grip strength
The variation in had grip strength and thumb pinch after the procedure (the day after and at 30 day follow-up) compared to baseline in patients with patent radial artery compared to occluded radial artery.
Measured: 3 months
Secondary outcomes (1)
Radial occlusion
The rate of radial occlusion after transradial coronary procedures
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startJul 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radial Artery OcclusionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Sandro Pertini, Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Sciahbasi, MD, Ospedale Sandro Pertini, Roma
- Investigators
- Alessandro Sciahbasi, MD, Principal investigator, Ospedale Sandro Pertini - ASL RMB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01853943
- Sponsor's protocol ID
- Pertini-02
- Acronym
- HANGAR
- Status last verified
- Mar 2015
- First submitted
- 10 May 2013
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand Grip Test After Transradial Percutaneous Coronary Procedures
- ClinicalTrials.gov ID
- NCT01853943
- Acronym / sponsor ID
- HANGAR / Pertini-02
- Conditions
- Radial Artery Occlusion
- Keywords
- Transradial approach, radial occlusion, hand grip, coronary angiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Ospedale Sandro Pertini, RomaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 May 2013 (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.
Transradial coronary procedures are gaining in popularity worldwide. A possible complication of transradial approach is the occlusion of the radial artery that in most cases is asymptomatic. However the investigators do not know if the radial artery occlusion may impact over the muscle force of the hand or fingers.
To evaluate if transradial approach for percutaneous coronary procedures may affect muscle force of the hand, thumb and index finger the investigators use a standardized hand-grip manometer and a pinch gauge before the transradial procedure, the day after the procedures and after few months.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patent radial artery | – | –Patient with patent radial artery after the percutaneous coronary procedure |
| Occluded radial artery | – | –Patients with occluded radial artery after the procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stable patients who undergo elective percutaneous transradial coronary procedures
Key inclusion criteria (1 listed)
- Stable patients who undergo elective percutaneous transradial coronary procedures
Key exclusion criteria (5 listed)
- hemodynamic instability,
- acute coronary syndromes,
- haemodialysis patients with an arteriovenous fistula,
- sheath diameter > 6 French,
- age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hand grip strength
Time frame: 3 months
The variation in had grip strength and thumb pinch after the procedure (the day after and at 30 day follow-up) compared to baseline in patients with patent radial artery compared to occluded radial artery.
1 secondary outcome
Radial occlusion
Time frame: 3 months
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 3 Mar 2015.
Related trials for Radial Artery Occlusion
Recruiting
DIStal Versus COnventional Radial Access for COMPLEX Large-bore Percutaneous Coronary Intervention
Vascular Access Site Occlusion
Recruiting
Randomization of Single vs Multiple Arterial Grafts
Coronary Artery Disease, Heart Diseases
RecruitingObservational study
Radial Access Data in Vascular Interventions Registry
Radial Artery Occlusion, Radial Artery Spasm
Not yet recruitingPhase 4
SPARK Study - Sympathetic Periarterial Radial Block in Healthy Volunteers
Healthy Volunteers, Sympathetic Activity
Recruiting
Timing of Anticoagulant Administration During Radial Access Percutaneous Coronary Intervention: the HERA-PCI Study (Heparin Early for Radial Access Percutaneous Coronary Intervention)
Coronary Angiography, Percutaneous Coronary Intervention
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.
Alessandro Sciahbasi, MD principal investigator
Ospedale Sandro Pertini - ASL RMB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radial Artery Occlusion, run by Ospedale Sandro Pertini, Roma at 1 site in Italy.
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 5 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 3 Mar 2015. 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 Italy. 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?
Hand grip strength (time frame: 3 months). 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 3 Mar 2015.