Phase II Study for the Diagnosis and Functional Assessment of CAD Using Transthoracic-Echodoppler

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and tolerance of a dipyridamole/adenosine combination given intravenously, as a slow bolus and at low doses to adenosine alone (given at its recommended dosage adjusted to patients' weight) for coronary flow reserve assessment (in 60-75 patients with stable ischemic heart disease) using transthoracic echodoppler

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Adenobio N.V
• Treatments: Adenosine; Dipyridamole

Criteria

Inclusion Criteria:

• Man or post-menopausal woman or with an oral contraceptive treatment , > 18 years

• Provided written consent by patient with good understanding of the study objectives as explained by the investigator during the initial visit

• Patient with a potential or known Coronary Artery Disease

• Patient for whom transthoracic ultrasonography for coronary reserve assessment is deemed useful

Exclusion Criteria:

• Subjects under 18, pregnant or breast-feeding woman, psychotic patients or subjects placed under administrative and legal authority

• Patients judged by investigator as not able to understand the study objectives

• Patients with a medical history, in particular a heart disease history (eg AV block) judged as non eligible by investigator

• Patients whose medical treatment contra- indicates their inclusion in the study (eg chronic use of oral dipyridamole, pentoxifylline), if not stopped at least 72 hours before the study test

• Patients with symptomatic bradycardia (<40 beat/min) or with systemic hypotension (SBP > 90 mmHg

• Patients with a 2nd and 3rd degree AV block, a sick sinus syndrome, but not those with artificial pacemaker

• Patients with prolonged QT (QTc>480 ms)

• Patients with oral dipyridamole who did not stopped their medication 48hrs before the study test

• Patients who received theophylline within 5 days before study test

• Consumption of coffee, cola, tea, chocolate within 12 hrs before study test

• Patients with a history of unstable Asthma or Chronic Obstructive Pulmonary Disease with bronchoconstriction

• Patients with unstable angina pectoris or uncontrolled severe heart failure

• Patients with a recent myocardial infarction history (<7 days), or stroke episode (< 1 month)

• Patients with known TC stenosis and not yet revascularized, uncontrolled hypovolemia, known and unfixed valvular stenosis, left-right shunt, pericarditis, sympathetic nervous system dysfunction, carotid stenosis , any significant cerebrovascular insufficiency

• Patients with known allergy to adenosine or dipyridamole