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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00723281
Enrollment
18
Registered
2008-07-28
Start date
2007-01-31
Completion date
2013-04-30
Last updated
2019-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Heart Transplantation

Keywords

transplant coronary artery disease, CT angiography, conventional angiography, intravascular ultrasound, Heart transplant patients with known transplant coronary artery disease

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.

Interventions

None listed

Sponsors

American Roentgen Ray Society
CollaboratorOTHER
University of California, San Francisco
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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 studyCTA studies will be done in an interval of 1 day to 30 days before the invasive studies

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026