NCT00403299

Brief Summary

Heart transplanted patients often develop coronary artery disease and therefore have their coronary arteries examined with coronary angiography once a year.The purpose of the study is to validate computer tomography of the coronary arteries against coronary angiography and intravascular ultrasound in heart transplanted patients. Additionally the association between different inflammatory markers and the development of CAD specific to heart transplanted patients will be studied.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Mar 2006

Shorter than P25 for not_applicable coronary-artery-disease

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 23, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

July 6, 2011

Status Verified

April 1, 2008

First QC Date

November 22, 2006

Last Update Submit

July 3, 2011

Conditions

Coronary Artery Disease

Keywords

Coronary artery diseaseCardiac transplantationCoronary artery disease in heart transplanted patients

Outcome Measures

Primary Outcomes (1)

  • Coronary artery disease found on computer tomography examination at the date of examination.

Secondary Outcomes (2)

  • Coronary artery disease found on coronary angiography at the date of examination.

  • Coronary artery disease found on intravascular ultrasound examination at the date of examination.

Interventions

MDCT of the coronary arteries.PROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Heart transplanted patient
  • Age 18 or above.

You may not qualify if:

  • Heart transplantation less than a year ago.
  • Renal insufficiency with estimated creatinine clearance \< 50 ml/min.
  • History of contrast induced nephropathy.
  • Known allergic reaction to CT contrast.
  • Pregnancy
  • Atrial Fibrillation
  • Severe heart failure NYHA class IV.
  • Hypotension (systolic blood pressure (BP) \< 100 mmHg and/or diastolic BP\<50 mmHg) or hemodynamic unstable patients.
  • Severe pulmonary disease making the patient unable to hold his/her breath in more than 10 seconds.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rikshospitalet-Radiumhospitalet HF

Oslo, 0027, Norway

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Anne Günther, MD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 22, 2006

First Posted

November 23, 2006

Study Start

March 1, 2006

Study Completion

March 1, 2007

Last Updated

July 6, 2011

Record last verified: 2008-04

Locations

NO(1)