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

NCT01593644 | Unknown Phase 2

• 1 other identifier: ADEN-Ph2-2011-1
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Ischemic Heart Disease

Keywords

Dipyridamole/adenosine combination given intravenously; slow bolus and low doses; coronary flow reserve assessment; transthoracic echodoppler; Patients; stable

Outcome Measures

Primary Outcomes (1)

• Diastolic mean and peak coronary blood velocities

  hemodynamic efficacy, with maintenance of the optimal hyperemic coronary effect for at least 45 to 60 seconds after the end of the injection

  2 minutes

Secondary Outcomes (1)

• Incidence rate and severity of adverse events, in particular, chest pain, dyspnoea, hypotension, bradycardia, AV blocks, arrhythmia.

  24 hours

Study Arms (1)

adenosine + dypiridamole

EXPERIMENTAL

Drug: adenosine + dipyridamole

Interventions

adenosine + dipyridamole DRUG

adenosine / dipyridamole combination given intravenously as a slow bolus at low doses

Also known as: Adenosine : Krenosin® vials with 6 mg of adenosine in 2 ml fluid, concentration of 3 mg /ml), Dipyridamole : injectable Persantine® - vials of 10 mg/2 ml

adenosine + dypiridamole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Adenobio N.V: lead

Study Sites (1)

Centre Hospitalier de Compiègne

Compiègne, 60321, France

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Adenosine; Dipyridamole; Fluid Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Drug Therapy; Therapeutics

Study Officials

• Patrick Meimoun, PhD

  Centre Hospitalier de Compiègne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe GORNY, PhD,MD

CONTACT

+33 616 764 464; pg@adenobio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2012
• First Posted: May 8, 2012
• Study Start: June 1, 2011
• Primary Completion: March 1, 2013
• Last Updated: September 7, 2012

Record last verified: 2012-09

Locations

FR (1)