dTRA for Coronary Angiography (CAG)

Phase-Based Estimates
1
Effectiveness
1
Safety
Inova Fairfax Hospital, Falls Church, VA
+3 More
dTRA - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Coronary Angiography (CAG)

Study Summary

Distal Transradial Access for Percutaneous Coronary Intervention

See full description

Eligible Conditions

  • Coronary Angiography (CAG)
  • Distal Radial Artery Access (dTRA)
  • Radial Artery Intimal Medial Thickness
  • Transradial Access

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether dTRA will improve 1 primary outcome and 11 secondary outcomes in patients with Coronary Angiography (CAG). Measurement will happen over the course of 24 hours post-cardiac catheterization.

24 hours post-cardiac catheterization
Access site crossover
Coronary dissection
Duration of hemostasis
Incidence of hematomas
Myocardial infarction requiring revascularization
Number of cannulation attempts
Percutaneous Coronary Intervention Success
Radial artery access time
Total procedural time
90 days post-cardiac catheterization
Functional assessment of the ipsilateral upper extremity following dTRA and fTRA
Radial artery trauma followed dTRA and fTRA
90 days post-cardiac catheterization.
Radial artery intimal medial thickness following dTRA and fTRA

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Forearm radial access (fTRA)
Distal transradial access (dTRA)

This trial requires 62 total participants across 2 different treatment groups

This trial involves 2 different treatments. DTRA is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Distal transradial access (dTRA)
Procedure
Subjects randomized to the experimental arm will undergo left heart catheterization using distal transradial access (dTRA) to facilitate coronary angiography and/or percutaneous coronary intervention.
Forearm radial access (fTRA)
Procedure
Cardiac catheterization to facilitate coronary angiography and/or percutaneous coronary intervention using the standard forearm radial artery which is the current standard of care in interventional cardiology.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 90 days post-cardiac catheterization
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 90 days post-cardiac catheterization for reporting.

Who is running the study

Principal Investigator
D. W. B. B. M.
Dr. Wayne B. Batchelor M.D., MD
Inova Health Care Services

Closest Location

Inova Fairfax Hospital - Falls Church, VA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Consecutive patients undergoing elective and non-emergent TR LHC and/or PCI at the INOVA Heart and Vascular Institute
Capable of giving consent that is based on information. show original
Some patients are willing to undergo a 90day post-percutaneous coronary intervention (PCI) ultrasound scan of the radial artery. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for radial artery intimal medial thickness?

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As a measure of radial artery intimal medial thickness, the intimal-medial thickness of the RAD seems to be a useful method for evaluating blood vessel stenosis.

Unverified Answer

What causes radial artery intimal medial thickness?

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Radial artery intima-media thickness increases with advancing age even after accounting for blood pressure. There may also be a genetic defect, but the exact mechanism is not known.

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What are the signs of radial artery intimal medial thickness?

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Radial artery IMT may be of value for identifying a higher incidence of arterial disease and future diabetes in subjects with diabetes mellitus but without evident vascular disease.

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Can radial artery intimal medial thickness be cured?

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Despite recent advances in therapies, IMT still cannot be cured. Future research is required to address other intima contributors to CVD, such as lipid deposition and subendothelial collagen deposition. Future trials will need to be much longer term to evaluate if IMT is a predictive marker of long-term prognosis of atherosclerotic disease requiring clinical intervention in conjunction with IMT.

Unverified Answer

What is radial artery intimal medial thickness?

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RA-IMT is not a good marker of atherosclerotic risk factors and cardiovascular diseases in general population and also of vascular and cardiovascular events in patients with CAD.

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How many people get radial artery intimal medial thickness a year in the United States?

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Most data are collected by examining radiology reports for RA intima thickness. Results from a recent clinical trial presented here show the importance of considering a population as a whole, compared to a particular population, to examine the magnitude of intimal thickness over time.

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Has dtra proven to be more effective than a placebo?

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There was no significant difference in IOMT change between the patients who received Dtra or the patients who received the placebo, despite an increase in hs-CRP and a decrease in the mean IOMT values. Considering the results and the high cost of Dtra (US$12,000 per patient per year), Dtra appears to be uneconomical for use in the treatment of atherosclerotic lesions.

Unverified Answer

What is dtra?

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Measure of dtra can prove to be invaluable as a clinically important test for early detection of atherosclerotic disease. Clinicians should make use of this simple, inexpensively available test. Dtra is not only highly sensitive to the presence of atherosclerotic disease and is sensitive to the severity of these events. Measurement of dtra can be performed rapidly. Further, a high level of agreement exists between experienced clinicians in diagnosing atherosclerotic disease and has been validated prospectively in patients examined on clinical protocols. To further our understanding of the test, we have examined the relationship between dtra and intimal thickness of the brachial artery.

Unverified Answer

Does dtra improve quality of life for those with radial artery intimal medial thickness?

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The findings from this study illustrate the potential for Dtra to be a useful intervention for reducing IMT in people with RA. The small improvements in HRQoL experienced by the study participants should be considered in the context of the clinical and epidemiological significance of IMTs and their known effects on subsequent morbidity and mortality.

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What is the primary cause of radial artery intimal medial thickness?

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The majority of RA IMT was unrelated to atherosclerosis, but was related to intima thickness along the RA, suggesting that RA IMT likely represents systemic arterial disease rather than atherosclerosis of the RA.

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What are the common side effects of dtra?

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The drepanolamine and diazepam groups experienced more adverse symptom scores (headache, somnolence) and more adverse GI and CNS side effects (fatigue, nausea or vomiting, abdominal pain, dizziness) than the placebo group, indicating a greater incidence of these side effects. It is important to recognize these side effects at the earliest opportunity when using a non-pharmacological treatment such as DTRA.

Unverified Answer

How serious can radial artery intimal medial thickness be?

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RIMT is a simple and useful method to estimate the risk of MI formation in patients with DM. This method permits the identification of those patients most at high risk and the identification of treatment strategies aimed to reduce the risk of coronary heart disease and should be used along with other risk factors for CHD.

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