Informations générales (source: ClinicalTrials.gov)
Phase 2, Monocentric, Single Blind Study, Comparing the Efficacy and Tolerance of a Dipyridamole/Adenosine Combination Given Intravenously, as a Slow Bolus and at Low Doses to Adenosine Alone for Coronary Flow Reserve Assessment (in Patients With Stable Ischemic Heart Disease) Using Transthoracic Echodoppler
Interventional
Phase 2
Adenobio N.V (Voir sur ClinicalTrials)
juin 2011
29 juin 2024
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
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre Hospitalier de Compiègne - 60321 - Compiègne - France | Patrick MEIMOUN | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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