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. 2011 Dec 7;2011(12):CD008691. doi: 10.1002/14651858.CD008691.pub2

Vandenberg 1996.

Clinical features and settings Clinical features
  • Patients with kidney disease and DM referred for kidney and/or pancreas transplantation from 1988 to 1993 undergoing cardiac evaluation as part of transplant workup with no history of angina, MI, coronary artery bypass surgery, or percutaneous transluminal coronary angioplasty; pharmacologic stress thallium scintigraphy and/or exercise radionuclide ventriculography performed as part of the evaluation; and coronary artery angiography performed within 6 months after the radionuclide evaluation (and no cardiac symptoms in the interim period).


Setting
  • Cardiovascular Center, University of Iowa College of Medicine, Iowa, USA

Participants
  • Number: 47

  • DM: 100%

  • Angina pectoris or IHD: Nil

  • Hypertension: 74%. 35/74 (74%)

    • Patients were taking antihypertensive medications, including beta blockers and calcium channel blockers; medications were continued during stress testing

  • Sex: not reported

Study design Cohort study
Target condition and reference standard(s) Coronary artery stenosis measured by coronary angiography
  • CAD defined as presence of ≥ 1 coronary arteries with ≥ 75% diameter stenosis. Separate data available for 50% stenosis

Index and comparator tests Pharmacologic stress thallium scintigraphy
  • IV dipyridamole was infused at a rate of 0.142 mg/kg per min for 4 min. IV adenosine was infused at a rate of 0.14 mg/kg per min for 6 min. Thallium‐201 (3 mCi) was injected IV 5 min after the completion of the dipyridamole infusion or 4 min after the beginning of the adenosine infusion. Imaging was performed within 10 min with a gamma‐camera. Planar images in anterior and lateral projections were obtained and were followed immediately by single‐photon emission CT imaging. Images were interpreted by consensus of two experienced radiologists who were unaware of the angiography results. Test results were considered abnormal if either a fixed or a reversible defect was present.


Exercise radionuclide ventriculography
  • Radionuclide ventriculography was performed in 40 patients using a modified in vivo red blood cell‐labelling technique with an initial IV injection of 5.1 mg of stannous pyrophosphate, followed by 25 to 30 mCi of technetium‐99m pertechnetate. Patients performed semi supine exercise with a bicycle ergometer table during continuous 12‐lead ECG monitoring. Exercise was begun at a pedal speed of 50 rpm and a work load of about 50 watts, which was increased by 10 watts every 30 sec to a symptom‐limited maximum. Heart rate and blood pressure were recorded at each exercise level. Images were obtained in the left anterior oblique projection at peak exercise and ejection fraction was calculated from this image. Exercise was considered adequate if the peak rate pressure product was > 20,000 or if the rate pressure product at least doubled from baseline to peak exercise.

  • A test result was considered abnormal if any of the following were present:

    • resting ejection fraction of < 50%

    • failure to increase ejection fraction by at least 5 percentage points (in female subjects and in those with a resting ejection fraction of > 60%, the failure to increase ejection fraction was not considered abnormal); or

    • a new wall motion abnormality with exercise

Follow‐up The mean time from thallium scintigraphy to the latest follow‐up visit was 35 ± 19 months.
Notes  
Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Yes Renal failure patients undergoing cardiac evaluation as part of transplant workup.
Acceptable reference standard? 
 All tests Yes Yes, coronary angiography with a reference standard threshold of ≥75% stenosis.
Acceptable delay between tests? 
 All tests Yes Angiography was performed 55 ± 42 days after thallium scintigraphy in 42 patients and 50 ± 45 days after exercise radionuclide ventriculography in 40 patients.
Partial verification avoided? 
 All tests Yes All participants who received an index test received the reference standard test.
Differential verification avoided? 
 All tests Yes This was not an issue in this study. Disease status (CAD) is diagnosed only through coronary angiography.
Incorporation avoided? 
 All tests Yes This was not an issue in this study. Disease status (CAD) is diagnosed only through coronary angiography.
Reference standard results blinded? 
 All tests Yes Measurements were made by a single observer without knowledge of the results of the imaging tests.
Index test results blinded? 
 All tests Yes Images were interpreted by the consensus of two experienced radiologists who were unaware of the angiography results.
Relevant clinical information? 
 All tests Yes Relevant clinical information was provided regarding the performance and analysis of both the index and reference tests.
Uninterpretable results reported? 
 All tests Yes Yes. One MPS was technically suboptimal and was therefore not included in the analysis. Exercise ventriculography was suboptimal in five patients and they were not included in the analysis.
Withdrawals explained? 
 All tests Yes All patients missing from the final analysis were accounted for.