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Comparison of CT Angiography With Conventional Angiography and Intravascular Ultrasound in Heart Transplant Patients

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
American Roentgen Ray Society
Information provided by (Responsible Party):
Karen Ordovas, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00723281
First received: July 24, 2008
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

The overall goal of this study is to determine if non-invasive imaging with state of the art CT coronary angiography can be used to screen for transplant coronary artery disease in the setting of heart transplant.

Our current protocol at UCSF for heart transplant patients involves screening with stress tests as well as coronary angiograms with intravascular ultrasound to assess the diameter of the lumen of the coronary arteries and to assess wall thickness.


Condition
Heart Transplantation
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparison of CT Angiography With Conventional Angiography and Intravascular Ultrasound in Heart Transplant Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Based on these considerations, 18 patients will be recruited to participate in this study, including at least 10 patients with coronary allograft vasculopathy. Only CTA of patients with positive echocardiographic stress test will be included in the study [ Time Frame: CTA studies will be done in an interval of 1 day to 30 days before the invasive studies ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: January 2007
Estimated Study Completion Date: April 2013
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Detailed Description:

Our hypothesis is that state of the art CT coronary angiography can be used to acquire data regarding the coronary arteries in the setting of heart transplant and be used to risk stratify patients with regards to the developments of transplant coronary artery disease.

Specific Aim 1- To test the hypothesis that coronary CTA can accurately measure cross-sectional vessel wall area using conventional coronary angiography with intra-vascular ultrasound as the standard of reference.

Specific Aim 2- To test the hypothesis that coronary CTA can accurately measure cross-sectional vessel wall thickness, vessel area and luminal area using conventional coronary angiography with intra-vascular ultrasound as the standard of reference.

Secondary Aim - To asses the correlation of cross-sectional vessel wall area, vessel wall thickness, vessel area, luminal area and vessel wall index with global and regional left ventricular function using coronary CTA.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All heart transplant patients at UCSF with known transplant coronary artery disease will be candidates for the study

Criteria

Inclusion Criteria:

  1. Patient referred for coronary angiography and IVUS as part of their standard clinical care;
  2. Patients must be 18 years of age or older.
  3. Any ethnic background is acceptable.

Exclusion Criteria:

  1. Patients with contraindications for the use of iodinated contrast (allergic reaction, renal failure, multiple myeloma, etc) will be excluded.

  2. Patients with heart rate higher than 65 bpm and contraindications for the use of beta-blockers, listed below:

    Systolic blood pressure < 90mmHg Decompensated congestive heart failure; COPD or asthma in use of bronchodilator; Second or third degree heart block; Severe aortic stenosis, defined by a pressure gradient higher than 50 mmHg and/or the presence of symptoms.

  3. Patients with contraindications for the use of nitroglycerin, listed below:

    Severe anemia; Increased intracranial pressure; Known hypersensitivity; Use of Sildenafil Citrate (Viagra®)

  4. Children and pregnant women will be excluded because of risks associated with radiation exposure.
  5. Patients must have no atrial fibrillation, as this will interfere with cardiac gating for the examination.
  6. Patients unable to give informed consent will be excluded as well.
  7. Patients with a coronary stent placed.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00723281

Locations
United States, California
UCSF Medical Center
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
American Roentgen Ray Society
Investigators
Principal Investigator: Charles B Higgins, MD UCSF Department of Radiology
  More Information

Publications:
Efron B, Tibshirani R. An Introduction to the Bootstrap. New York: Chapman and Hall; 1993
Kish. Survey Sampling. New York: Wiley & Sons; 1965.

Responsible Party: Karen Ordovas, Assistant Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00723281     History of Changes
Other Study ID Numbers: H627-29905
Study First Received: July 24, 2008
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
transplant coronary artery disease
CT angiography
conventional angiography
intravascular ultrasound
Heart transplant patients with known transplant coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013