Ischemic Heart DiseaseNCT03373565
Snuff-box Deep Palmar Arch Artery Versus Radial Angiography
A study testing Radial and Palmar in people with Ischemic Heart Disease, run by Hamidreza Mahboobi at 1 site in Iran.
Trial summary
Angiography is a common diagnostic and therapeutic procedure in patients with acute coronary syndrome (ACS). The complications are variable between mild self-limited complications to severe life-threatening complications which need early interventions. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Radial and Palmar
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIran
- Study dates
- 1 Jul 2017to 30 Dec 2017
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- indication of coronary artery angiography confirmed by a cardiologist
- Accepting to sign the written informed consent
Who cannot join
- No follow up visit after one-month period
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Hormozgan University of Medical Sciences
Bandar Abbas, Hormozgan
Hosein Farshidi, M.D, 9173613517 ext. +98, hfarshidi6@gmail.com
About this study
Angiography is a common diagnostic and therapeutic procedure in patients with acute coronary syndrome (ACS). The complications are variable between mild self-limited complications to severe life-threatening complications which need early interventions.
New angiographic methods are associated with variable complications. Death, myocardial infarction, and stroke are among major angiography complications. In addition, some local complications including bleeding at the site of insertion, infection, arteriovenous fistula, pseudoaneurysm, and thrombosis is reported after angiography.
Read more
Radial and femoral methods are common angiographic methods. Its shown that radial method is associated with less complications and patients need shorter duration of hospitalization.
Radial artery thrombosis is common complication of radial angiography. However, the prevalence is between 5 to 19 percent but often it is not clinically important. Risk of ischemia due to thrombosis is low because of blood flow in radial and ulnar and collaterals. In patients with incomplete palmar arch this is important and may cause ischemia.
The aim of this study is to compare the outcomes of coronary angiography using Snuff-box deep palmar arch artery and radial artery in patients attending angiography center of Shahid Mohammadi hospital in Bandar Abbas in 2017.
- Conditions
- Ischemic Heart Disease
- Being tested
- Radial, Palmar
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadialProcedure or surgery
Coronary angiography using radial approach
PalmarProcedure or surgery
Coronary angiography using radial approach
| Study group | Role | What they receive |
|---|---|---|
| Radial | Active comparator | Coronary angiography using radial approach Receives: Procedure: Radial |
| palmar | Experimental | Coronary angiography using palmar approach Receives: Procedure: Palmar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombosis
Thrombosis at the site of angiography using ultrasonography
Measured: 1 months
Secondary outcomes (4)
Infection
Number of patients with infection at the site of angiography in physical examnination
Measured: 1 months
Pain
Number of patients with pain at the site of angiography using questionnaire
Measured: 1 months
Numbness
Number of patients with numbness at the site of angiography using questionnaire
Measured: 1 months
Loss of movement
Number of patients with loss of movement at the site of angiography in physical examination
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start1 Jul 2017
- Primary completion20 Dec 2017 (estimated)
- Study completion30 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamidreza Mahboobi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hamidreza Mahboobi, Hormozgan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373565
- Sponsor's protocol ID
- HUMS.REC.1396.82
- Status last verified
- Dec 2017
- First submitted
- 18 Nov 2017
- Last updated
- 14 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Snuff-box Deep Palmar Arch Artery Versus Radial Angiography
- ClinicalTrials.gov ID
- NCT03373565
- Acronym / sponsor ID
- HUMS.REC.1396.82
- Conditions
- Ischemic Heart Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hamidreza MahboobiUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 20 Dec 2017 (estimated)
- Study completion
- 30 Dec 2017 (estimated)
- First posted
- 14 Dec 2017 (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.
Angiography is a common diagnostic and therapeutic procedure in patients with acute coronary syndrome (ACS). The complications are variable between mild self-limited complications to severe life-threatening complications which need early interventions.
New angiographic methods are associated with variable complications. Death, myocardial infarction, and stroke are among major angiography complications. In addition, some local complications including bleeding at the site of insertion, infection, arteriovenous fistula, pseudoaneurysm, and thrombosis is reported after angiography.
Radial and femoral methods are common angiographic methods. Its shown that radial method is associated with less complications and patients need shorter duration of hospitalization.
Radial artery thrombosis is common complication of radial angiography. However, the prevalence is between 5 to 19 percent but often it is not clinically important. Risk of ischemia due to thrombosis is low because of blood flow in radial and ulnar and collaterals. In patients with incomplete palmar arch this is important and may cause ischemia.
The aim of this study is to compare the outcomes of coronary angiography using Snuff-box deep palmar arch artery and radial artery in patients attending angiography center of Shahid Mohammadi hospital in Bandar Abbas in 2017.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radial | Active comparator | Procedure: RadialCoronary angiography using radial approach |
| palmar | Experimental | Procedure: PalmarCoronary angiography using palmar approach |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- indication of coronary artery angiography confirmed by a cardiologist
- Accepting to sign the written informed consent
Key exclusion criteria (1 listed)
- No follow up visit after one-month period
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 |
|---|---|---|
| RadialCoronary angiography using radial approach | Procedure or surgery | Radial |
| PalmarCoronary angiography using radial approach | Procedure or surgery | palmar |
Primary outcome
Thrombosis
Time frame: 1 months
Thrombosis at the site of angiography using ultrasonography
4 secondary outcomes
Infection
Time frame: 1 months
Pain
Time frame: 1 months
Numbness
Time frame: 1 months
Loss of movement
Time frame: 1 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2017.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radial and Palmar in people with Ischemic Heart Disease, run by Hamidreza Mahboobi at 1 site in Iran.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Dec 2017. 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 Iran. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hosein Farshidi, M.D (09173613517 ext. +98, hfarshidi6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombosis (time frame: 1 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 14 Dec 2017.