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

Completed

• Conditions: Coronary Artery Disease; Heart Transplantation

• Registration Number: NCT00723281
• Lead Sponsor: University of California, San Francisco

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2008-07-24
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-28
• Primary Completion: 2010-07
• Study Completion: 2013-04
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-13
• Last Update Posted: 2019-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	CTA studies will be done in an interval of 1 day to 30 days before the invasive studies

Trial Locations

Locations (1)

UCSF Medical Center; 🇺🇸 San Francisco, California, United States