Clinical trial NCT00723281: Comparison of CT Angiography With Conventional Angiography and Intravascular Ultrasound in Heart Transplant Patients
Official title: Comparison of CT Angiography With Conventional Angiography and Intravascular Ultrasound in Heart Transplant Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Transplantation
Coronary Artery Disease
Keywords: transplant coronary artery disease
CT angiography
conventional angiography
intravascular ultrasound
Heart transplant patients with known transplant coronary artery disease
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: American Roentgen Ray Society
First posted: 2008-07-28
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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 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.

Primary outcomes:
measure: 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
timeFrame: CTA studies will be done in an interval of 1 day to 30 days before the invasive studies
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
Study officials:
affiliation: UCSF Department of Radiology
name: Charles B Higgins, MD
role: PRINCIPAL_INVESTIGATOR
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