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OpenTrials
Completed

NCT Number: NCT00944294

Efficacy and Safety Study of Binodenoson in Assessing Cardiac Ischemia

Binodenoson (an experimental drug) and adenosine (an FDA-approved drug that is currently used by doctors) are used to increase blood flow to the heart just like when a person exercises on a treadmill. Using imaging techniques, this increased blood flow can help determine if areas of the heart are not getting enough blood and oxygen during exercise. The purpose of the study is to determine if binodenoson is as good as adenosine in determining if there are areas of the heart not getting enough oxygen when blood flow to the heart is increased.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Able to understand and sign an informed consent form.

Exclusion criteria

  • Women who are of childbearing potential.
  • Very low likelihood of coronary artery disease (by American Heart Association and American College of Cardiology standards).
  • Documented history of acute myocardial infarction within 30 days.
  • Percutaneous coronary intervention or coronary bypass graft surgery within 3 years, unless typical or atypical anginal symptoms are present.
  • Reactive airway disease or other contraindication that preclude a patient from receiving adenosine.
  • Previous heart transplant or listed to receive a heart transplant.
  • Cardiomyopathy (idiopathic dilated, restrictive, hypertrophic).
  • History of hemodynamically significant supraventricular tachycardia or sustained ventricular tachycardia.
  • Presence of second- or third-degree AV block (in the absence of permanent pacemaker).
  • Left ventricular ejection fraction greater than 35%, known prior to the first imaging procedure.
  • Presence of advanced heart failure, New York Heart Association Class IV.
  • History of vasospastic/Prinzmetal angina.
  • Active (under treatment) cancer (except skin cancers).
  • Inability to discontinue antianginal medications, Aggrenox®, dipyridamole, and xanthine-containing drugs and foods (including caffeine) as required prior to each imaging procedure.
  • Previous participation in a study of binodenoson.
  • Any physical or psychosocial condition that, based on the Investigator's judgment, would prevent the patient from completing the study.

Treatment and study plan

binodenoson

Drug

30-second intravenous injection (bolus) of binodenoson (1.5 mcg/kg) and a 6-minute intravenous infusion of placebo

Other names: CorVue

Adenosine

Drug

30-second intravenous injection (bolus) of placebo and a 6-minute intravenous infusion of adenosine (140 mcg/kg/minute)

Primary outcomes

  1. Difference in binodenoson and adenosine reader-generated Summed Difference Scores

    Time frame: 2 to 7 days apart

  2. Extreme discrepancies in binodenoson and adenosine reader-generated Summed Difference Scores

    Time frame: 2 to 7 days apart

Secondary outcomes

  1. Categorized reader-generated Summed Difference Scores

    Time frame: 2 to 7 days apart

  2. Difference in reader-generated Summed Stress Scores

    Time frame: 2 to 7 days apart

  3. Extreme discrepant reader-generated Summed Stress Scores

    Time frame: 2 to 7 days apart

  4. Categorized reader-generated Summed Stress Scores

    Time frame: 2 to 7 days apart

  5. Sensitivity compared to coronary angiography

    Time frame: angiography obtained up to 60 days post-image

  6. Specificity compared to coronary angiography

    Time frame: angiography obtained up to 60 days post-image

  7. Sensitivity compared to clinical endpoint

    Time frame: clinical endpoint obtained up to 60 days post-image

  8. Specificity compared to clinical endpoint

    Time frame: clinical endpoint obtained up to 60 days post-image

  9. Incidence of second- or third-degree AV block

    Time frame: 0 to 60 minutes after start of study drug administration

  10. Patient-rated overall symptom bother

    Time frame: 1 hour post-dosing

  11. Patient preference for pharmacologic stress agent

    Time frame: 1 to 4 days following 2nd procedure

  12. Incidence of flushing

    Time frame: 0 to 60 minutes after start of study drug administration

  13. Patient-rated intensity of flushing

    Time frame: 0 to 60 minutes after start of study drug administration

  14. Incidence of chest pain

    Time frame: 0 to 60 minutes after start of study drug administration

  15. Patient-rated intensity of chest pain

    Time frame: 0 to 60 minutes after start of study drug administration

  16. Incidence of dyspnea

    Time frame: 0 to 60 minutes after start of study drug administration

  17. Patient-rated intensity of dyspnea

    Time frame: 0 to 60 minutes after start of study drug administration

  18. Incidence of nausea

    Time frame: 0 to 60 minutes after start of study drug administration

  19. Patient-rated intensity of nausea

    Time frame: 0 to 60 minutes after start of study drug administration

  20. Incidence of headache

    Time frame: 0 to 60 minutes after start of study drug administration

  21. Patient-rated intensity of headache

    Time frame: 0 to 60 minutes after start of study drug administration

  22. Incidence of abdominal discomfort

    Time frame: 0 to 60 minutes after start of study drug administration

  23. Patient-rated intensity of abdominal discomfort

    Time frame: 0 to 60 minutes after start of study drug administration

  24. Incidence of dizziness

    Time frame: 0 to 60 minutes after start of study drug administration

  25. Patient-rated intensity of dizziness

    Time frame: 0 to 60 minutes after start of study drug administration

  26. Overall incidence of adverse events

    Time frame: up to 7 days post-dosing

  27. Peak change in heart rate

    Time frame: 0 to 60 minutes after start of study drug administration

  28. Peak change in systolic blood pressure

    Time frame: 0 to 60 minutes after start of study drug administration

  29. Peak change in diastolic blood pressure

    Time frame: 0 to 60 minutes after start of study drug administration

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Vasodilator Induced Stress In CONcordance With Adenosine (VISION-302)

Acronym: VISION-302

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Jul 23, 2009
Registry last updated
Jun 1, 2012

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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