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OpenTrials
Completed

NCT Number: NCT00723281

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UCSF Medical Center

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

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

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

  • Children and pregnant women will be excluded because of risks associated with radiation exposure.
  • Patients must have no atrial fibrillation, as this will interfere with cardiac gating for the examination.
  • Patients unable to give informed consent will be excluded as well.
  • Patients with a coronary stent placed.

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • American Roentgen Ray Society

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2013
First posted
Jul 28, 2008
Registry last updated
Jun 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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