Imaging Modalities in Detection of Coronary Artery Disease in End-stage Renal Disease Patients

Stroke Clinical Trial

Official title:

Detection of Significant Coronary Artery Disease in Nephropathy Patients Utilizing Coronary CTA and Real Time Perfusion DSE: Comparison With Quantitative Coronary Angiography and Patient Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00726921
• Other study ID #: 0256-08-FB
• Status: Completed
• Start date: August 25, 2008
• Est. completion date: December 21, 2012

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study investigates hypothesizes that the combination of dobutamine stress echocardiography with dobutamine stress echocardiography with real time perfusion myocardial contrast echocardiography and coronary computed tomography is a better modality for detecting coronary artery disease in end-stage renal disease patients than coronary angiography, and in predicting patient outcomes. Demonstrating this would lead to increased use of DSE with RTCE and coronary CT at kidney transplant centers throughout the nation, leading to improved anatomical and functional detection of CAD without the need for further invasive procedures.

Description:

Primary: To examine the ability of dobutamine stress dobutamine stress echocardiography with real time perfusion (DSE with RTCE) and coronary computed tomographic angiography (cCTA) to detect anatomically significant coronary artery disease (CAD) as defined by quantitative coronary angiography in end-stage renal disease (ESRD) patients Secondary: To identify which of these tests is most predictive of patient outcomes.

This will be a pilot study enrolling 75 participants. This is based off obtaining 80% power and a 90% rectangular confidence region for sensitivity and specificity using one-sided confidence limits, this corresponds to two 95% univariate confidence intervals (one for sensitivity and one for specificity). With 73 patients screened in total there will be 80% power to form a 90% rectangular confidence region around 90% sensitivity and 90% specificity, excluding sensitivities less than 69% and specificities less than 73%. We believe the sensitivities and specificities of both DSE with RTCE and cCTA will be within these confidence regions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: December 21, 2012
• Est. primary completion date: December 21, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Diabetes mellitus

2. Patients undergoing kidney transplant evaluation.

3. Currently on hemodialysis

4. Adults 19-65 years of age

5. Written informed consent from a participant who is deemed medically competent by principal investigator, secondary investigators, or participating personnel as written in II.26 (b)

6. Male or female

Exclusion Criteria:

1. Previous history of percutaneous coronary intervention

2. Coronary artery bypass surgery

3. Prior myocardial infarction or AMI (troponin greater than 1.0) within 48 hours of the test

4. Atrial or ventricular arrhythmias that cannot be controlled to heart rates <65 beats per minute

5. Known allergy to iodinated contrast

6. Decompensated Congestive Heart failure

7. Acute respiratory failure as manifested by signs and symptoms of carbon dioxide retention or hypoxemia

8. Pregnant (based on history/information obtained from the patient)

9. Possibility that potential subject may be pregnant (based on history/information obtained from the patient)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Death
• Infarction
• Myocardial Infarction
• Myocardial Ischemia
• Stroke

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

References & Publications (33)

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Rakhit DJ, Armstrong KA, Beller E, Isbel NM, Marwick TH. Risk stratification of patients with chronic kidney disease: results of screening strategies incorporating clinical risk scoring and dobutamine stress echocardiography. Am Heart J. 2006 Aug;152(2):363-70. doi: 10.1016/j.ahj.2006.01.003. — View Citation

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Tsutsui JM, Elhendy A, Xie F, O'Leary EL, McGrain AC, Porter TR. Safety of dobutamine stress real-time myocardial contrast echocardiography. J Am Coll Cardiol. 2005 Apr 19;45(8):1235-42. doi: 10.1016/j.jacc.2005.01.024. — View Citation

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detect coronary artery disease (CAD) by invasive angiography in end-stage renal disease (ESRD) patients	To examine the ability of dobutamine stress echocardiography with real time perfusion (DSE with RTCE) and coronary computed tomographic angiography (cCTA) to detect anatomically significant coronary artery disease (CAD) as defined by invasive angiography in end-stage renal disease (ESRD) patients	One year
Secondary	Predictive Test	To identify which of these tests is most predictive of patient outcome	3 years