NCT00029575

Brief Summary

This study will compare four methods of imaging arteries:

  • angiography (x-ray picture)
  • intravascular ultrasound (ultrasound from inside the artery)
  • magnetic resonance imaging (MRI) from outside the body
  • MRI using an antenna to take pictures inside the arteries of the pelvis Standard angiography shows blockages inside the artery, but does not provide any information about the arterial wall itself. New ways of looking at the artery walls with MRI and ultrasound may provide insight into how arteries cause disease. Patients 21 years of age and older who require catheterization and angiography of the heart, kidney, or leg arteries because of atherosclerosis (narrowing of the arteries), may be eligible for this study. Participants will undergo MRI and intravascular ultrasound of the arteries immediately after their catheterization and angiography. The additional imaging will add from 1 to 2 hours to the angiogram procedure.
  • Angiography: Using the sheaths already in place in the groin artery, catheters (flexible plastic tubes) are placed inside the arteries in order to inject a contrast dye to take x-ray pictures. (Patients who had an angiogram of the leg artery as part of their medical care will not repeat this test.)
  • Intravascular ultrasound: An anti-clotting drug called heparin is given through a vein to prevent clot formation. Blood samples are taken during the test to see if more heparin is needed. Special wires are used to guide the catheters to the proper location inside the arteries. A special ultrasound catheter is advanced over one of these wires to the large artery that supplies blood to the legs. X-rays are used to help the physician place the ultrasound in the correct location to take ultrasound pictures of the artery wall.
  • Magnetic resonance imaging: A special MRI catheter is advanced through the catheter in the groin. With the catheter in place, the patient is carried to a stretcher and moved into a long metal cylinder (the MRI scanner) for imaging. During the scanning, a contrast drug called gadolinium is injected into an arm vein to brighten the images. The patient is able to speak through a microphone at all times to the person taking the pictures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2002

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
Last Updated

March 4, 2008

Status Verified

December 1, 2003

First QC Date

January 15, 2002

Last Update Submit

March 3, 2008

Conditions

Arteriosclerosis

Keywords

AtheroscleroticPlaqueResolutionAdventitiaUltrasoundCardiac CatheterizationArteriosclerosisCoronary Artery Disease

Interventions

Surgi-Vision Guidewire CoilDEVICE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients undergoing a clinically driven transfemoral diagnostic or therapeutic cardiac or peripheral catheterization procedure

You may not qualify if:

  • Contraindication to Heparin
  • Patients less than 21 years old
  • Pregnant or lactating women
  • Prior allergic reaction to Gadolinium contrast
  • Cardiac pacemaker or implantable defibrillator
  • Cerebral aneurysm clip
  • Neural stimulator (e.g. TENS-Unit)
  • Any type of ear implant
  • Metal in eye (e.g. from machining)
  • Any implanted device (e.g. insulin pump, drug infusion device)
  • Serum creatinine greater than 2.0 mg/dl
  • Decompensated congestive heart failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Barker SG, Tilling LC, Miller GC, Beesley JE, Fleetwood G, Stavri GT, Baskerville PA, Martin JF. The adventitia and atherogenesis: removal initiates intimal proliferation in the rabbit which regresses on generation of a 'neoadventitia'. Atherosclerosis. 1994 Feb;105(2):131-44. doi: 10.1016/0021-9150(94)90043-4.

    PMID: 8003089BACKGROUND

  • Scott NA, Cipolla GD, Ross CE, Dunn B, Martin FH, Simonet L, Wilcox JN. Identification of a potential role for the adventitia in vascular lesion formation after balloon overstretch injury of porcine coronary arteries. Circulation. 1996 Jun 15;93(12):2178-87. doi: 10.1161/01.cir.93.12.2178.

    PMID: 8925587BACKGROUND

  • Shi Y, O'Brien JE, Fard A, Mannion JD, Wang D, Zalewski A. Adventitial myofibroblasts contribute to neointimal formation in injured porcine coronary arteries. Circulation. 1996 Oct 1;94(7):1655-64. doi: 10.1161/01.cir.94.7.1655.

    PMID: 8840858BACKGROUND

MeSH Terms

Conditions

ArteriosclerosisPlaque, AmyloidCoronary Artery Disease

Condition Hierarchy (Ancestors)

Arterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsCoronary DiseaseMyocardial IschemiaHeart Diseases

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

January 15, 2002

First Posted

January 16, 2002

Study Start

January 1, 2002

Study Completion

December 1, 2003

Last Updated

March 4, 2008

Record last verified: 2003-12

Locations

US(1)