Cardiac CatheterizationPRACTICAL-IINCT03645837
Rapid Clamp Release Post Trans-radial Cardiac Catheterization
A study testing Compression clamp release in people with Cardiac Catheterization, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
The purpose of the study is to compare different short durations of radial clamp application following an angiogram via a trans-radial approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Catheterization
- What is being tested?
- Compression clamp release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2018to 1 Jun 2019
- Phase
- Interventional
- 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
Who may be able to join
- Diagnostic catheterization
- 5 F slender sheath
- Normal ulno-palmar circulation
Who cannot join
- Abnormal ulno-palmar circulation type D
- Ad hoc percutaneous coronary intervention
- Heparin or other anticoagulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Compression Duration Post Trans Radial Cardiac Catheterization
The purpose of the study is to compare different short durations of radial clamp application following an angiogram via a trans-radial approach.
Read the detailed description
This is a single-center, prospective, randomized study that will enroll patients that are referred for an angiogram and will compare 3 different durations of radial clamp applications. Patients will be randomly assigned to either 10, 20 or 30-minute clamp applications. The clamps will be gradually released at the end of the assigned durations and participants will be assessed for the radial artery occlusion, hematoma, and other bleeding events.
- Conditions
- Cardiac Catheterization
- Being tested
- Compression clamp release
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression clamp releaseOther
Standard compression clamp is used and will be released at different times according to randomization
| Study group | Role | What they receive |
|---|---|---|
| 10 minutes | Experimental | Compression clamp release start after 10 minutes Receives: Other: Compression clamp release |
| 20 minutes | Experimental | Compression clamp release start after 20 minutes Receives: Other: Compression clamp release |
| 30 minutes | Active comparator | Compression clamp release start after 30 minutes Receives: Other: Compression clamp release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematoma
Hematoma larger than 5 cm
Measured: 1 hour
Radial artery occlusion
Assessed by Doppler
Measured: 1 hour
Secondary outcomes (1)
Bleeding - any
Minor hematoma
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start1 Oct 2018
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac CatheterizationStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shahar Lavi, MD, Principal investigator, London Health Sceinces Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645837
- Sponsor's protocol ID
- 112619
- Acronym
- PRACTICAL-II
- Status last verified
- Feb 2019
- First submitted
- 22 Aug 2018
- Last updated
- 4 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lavi S, Cheema A, Yadegari A, Israeli Z, Levi Y, Wall S, Alemayehu M, Parviz Y, Murariu BD, McPherson T, Syed J, Bagur R. Randomized Trial of Compression Duration After Transradial Cardiac Catheterization and Intervention. J Am Heart Assoc. 2017 Feb 3;6(2):e005029. doi: 10.1161/JAHA.116.005029.
PubMed 28159821
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Compression Duration Post Trans Radial Cardiac Catheterization
- ClinicalTrials.gov ID
- NCT03645837
- Acronym / sponsor ID
- PRACTICAL-II / 112619
- Conditions
- Cardiac Catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 24 Aug 2018 (actual)
- 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.
The purpose of the study is to compare different short durations of radial clamp application following an angiogram via a trans-radial approach.
Detailed description
This is a single-center, prospective, randomized study that will enroll patients that are referred for an angiogram and will compare 3 different durations of radial clamp applications. Patients will be randomly assigned to either 10, 20 or 30-minute clamp applications. The clamps will be gradually released at the end of the assigned durations and participants will be assessed for the radial artery occlusion, hematoma, and other bleeding events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 10 minutes | Experimental | Other: Compression clamp releaseCompression clamp release start after 10 minutes |
| 20 minutes | Experimental | Other: Compression clamp releaseCompression clamp release start after 20 minutes |
| 30 minutes | Active comparator | Other: Compression clamp releaseCompression clamp release start after 30 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnostic catheterization
- 5 F slender sheath
- Normal ulno-palmar circulation
Key exclusion criteria (3 listed)
- Abnormal ulno-palmar circulation type D
- Ad hoc percutaneous coronary intervention
- Heparin or other anticoagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compression clamp releaseStandard compression clamp is used and will be released at different times according to randomization | Other | 10 minutes, 20 minutes, 30 minutes |
Primary outcome
Hematoma
Time frame: 1 hour
Hematoma larger than 5 cm
Radial artery occlusion
Time frame: 1 hour
Assessed by Doppler
1 secondary outcome
Bleeding - any
Time frame: 1 hour
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 4 May 2020.
- Background: PubMed 28159821Lavi S, Cheema A, Yadegari A, Israeli Z, Levi Y, Wall S, Alemayehu M, Parviz Y, Murariu BD, McPherson T, Syed J, Bagur R. Randomized Trial of Compression Duration After Transradial Cardiac Catheterization and Intervention. J Am Heart Assoc. 2017 Feb 3;6(2):e005029. doi: 10.1161/JAHA.116.005029.
- Individual participant dataSharing planned: No
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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.
Shahar Lavi, MD principal investigator
London Health Sceinces Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression clamp release in people with Cardiac Catheterization, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 3 inclusion and 3 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 4 May 2020. 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 Canada. 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?
Hematoma (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03645837, which also lists 1 linked publication.
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 4 May 2020.