NCT00001633

Brief Summary

Magnetic resonance imaging (MRI) is a diagnostic tool that creates high quality images of the human body without the use of X-ray (radiation). MRI is especially useful when studying the arteries of the heart (CMRA, coronary magnetic resonance angiography). In this study researchers from several laboratories and hospitals will work together to determine the safety and effectiveness of CMRA with MS-325. MS-325 is a contrast agent. It is given to patients undergoing CRMA in order to improve the appearance of the arteries of the heart.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 1997

Typical duration for phase_2

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

September 1, 1997

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2000

Completed
2 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

December 1, 1999

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Coronary Disease

Keywords

Contrast MediaCoronary Artery DiseaseCoronary VesselsMagnetic Resonance AngiographyMagnetic Resonance Imaging

Interventions

Coronary magnetic resonance angiography imagingPROCEDURE

Eligibility Criteria

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

You may not qualify if:

  • No metal implants or clips in field of view (FOV).
  • No female who is pregnant or currently lactating.
  • No recent history of clinically significant anemia (less than or equal to 8.0 g/dL).
  • No history of sickle cell anemia.
  • No clinical suspicion of worsening in vascular status of target artery between time of x-ray angiogram and MS-325 administration.
  • Not received warfarin within seven days prior to MS-325 administration.

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

MeSH Terms

Conditions

Coronary DiseaseCoronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesArteriosclerosisArterial Occlusive Diseases

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

September 1, 1997

Study Completion

December 1, 2000

Last Updated

March 4, 2008

Record last verified: 1999-12

Locations

US(1)