Clinical Trial Professionals: Contemporary Treatments in Cardiology

Cleveland Clinic presents

Contemporary Treatments in Cardiology

A 2-day comprehensive course that provides a combination of didactic and clinical cardiovascular experiences for Clinical Trials Professionals

Who should attend this course?

Persons involved in any aspect of clinical trial (single or multicenter) coordination whose objective is to increase understanding of clinical indication under studies:

• Clinical Trial Coordinators
• Sponsors
• CRAs
• CROs
• Operations/Project teams
• Sites
• Data Management

The symposium leaders are experts in the field of clinical research and have a combined average of 10-15 years of clinical and research experience. Experience of speakers enhances presentation of clinical content with specific relevance to the conduct of clinical trials.

Classroom sessions

• Angiography Core Laboratory
• Intravascular Ultrasound (IVUS) Core Laboratory
• Preventive Cardiology
• Vascular Access and Associated Equipment
• Unstable Angina/Acute Myocardial Infarction
• Basic ECG Interpretation
• Electrophysiology
• CEC Core Laboratory Procedures
• Cardiac Medications
• Congestive Heart Failure
• Coronary Interventions

Breakout sessions

• Cardiac Catheterization Lab
• Angiography and IVUS Core Lab Tours
• Observe in Coronary Intensive Care Unit
• Clinical Trials Screening
• Observe Echocardiography and Stress Laboratories
• Observe Heart Surgery (depends on surgical availability)

Course schedule

Objectives of the breakout sessions:

Percutaneous Coronary Intervention

At the completion of this presentation, the participant will be able to:

• describe the pathophysiology of lesion formation, the procedure, and medications utilized during the procedure
• list and describe five complications associated with the procedure
• be familiar with expected vs. unexpected complications related to PCI (i.e. bruising, CP with inflation)
• identify the current FDA approved treatment modalities

Equipment and Vascular Access

At the completion of this presentation, the participant will be able to:

• identify standard equipment utilized in obtaining vascular access
• define equipment used during a percutaneous coronary intervention
• differentiate between intracoronary stent, rotablator, transluminal extraction catheter and angioplasty balloon

Preventive Cardiology

At the completion of this presentation, the participant will be able to:

• identify the traditional and non-traditional risk factors for cardiovascular disease
• describe current pharmacologic and non-pharmacologic treatment strategies for cardiovascular risk reduction
• describe the current use of LDL aphresis as a treatment modality for hyperlipidemia

Congestive Heart Failure Presentation

At the completion of this presentation, the participant will be able to:

• discuss pathophysiology of heart failure related to neuroendocrine and inflammatory factor influences
• describe the four "core" chronic heart failure drugs and discuss two important key points of each related to administration

CEC/ECG Core Laboratory Procedures

At the completion of this presentation, the participant will:

• understand the CEC/ECG process, its foundation based on the protocol and inter-relatedness with monitoring and data management functions
• be familiar with the difference in endpoint determination by the case report form vs. Clinical Events Committee (CEC) adjudication

Cardiac Medications

At the completion of this presentation, the participant will be able to:

• demonstrate familiarity with medications commonly given during percutaneous coronary intervention, as well as the treatment of acute myocardical infarction, congestive heart failure, and unstable angina

Angiography Core Laboratory

At the completion of this presentation, the participant will be able to:

• define quantitative core angiography
• describe thrombolysis and myocardial infarction (TIMI) flow criteria

Intravascular Ultrasound Core Laboratory

At the completion of this presentation, the participant will be able to:

• define quantitative core ultrasound
• define the indications for intravascular ultrasound

Acute Myocardial Infarction (MI)/Unstable Angina

At the completion of this presentation, the participant will be able to:

• describe at least one indication for primary angioplasty vs. thrombolytic therapy
• list at least 3 different thrombolytics that may be used in the treatment of acute myocardial infarction
• describe the standard treatment methods for patients with unstable angina
• list 3 different anti-platelet agents that may be used in the treatment of unstable angina

Basic ECG Interpretation

At the completion of this presentation, the participant will be able to:

• identify a normal tracing
• identify significant arrhythmias (VT, VF, tachycardia vs. bradycardia)
• be familiar with basic conduction in the normal EKG
• be familiar with how to calculate a ventricular rate
• identify signs of ischemia on the ECG (T wave inversion, ST depression

Electrophysiology Presentation

At the completion of this presentation, the participant will be able to:

• comprehend the role of electrophysiologic testing in the differentiation of arrhythmias
• describe the three mechanisms of arrhythmia
• describe normal conduction activation

Cardiac Catheterization Laboratory

At the completion of this section, the participant will:

• be familiar with a procedure performed in the cath lab
• observe a cardiac catheterization and intervention
• be familiar with anticoagulation use and frequently used medications associated with caths and percutaneous transluminal coronary angioplasty (PTCA)
• be familiar with common angiographic views
• be familiar with TIMI frame counts

Angiography Core Laboratory Tour

At the completion of this section, the participant will be able to:

• identify equipment and methods utilized for imaging media tracking, visual and computer-assisted techniques utilized in the analysis of coronary and peripheral angiography
• understand database and case report form design

Intravascular Ultrasound Core Laboratory Tour

At the completion of this section, the participant will be able to:

• identify the equipment and methods used for imaging media tracking, database and forms design, visual and computer-assisted techniques used in the analysis of intravascular ultrasound

Clinical Trials Screening

At the completion of this section, the participant will be able to:

• understand 2 new strategies to identify patients eligible for clinical trials in unstable angina
• identify 2 factors that impact a patient's willingness to provide informed consent to participate in a clinical trial
• identify 3 tools to facilitate enrollment into clinical trials

Cardiac Intensive Care (CIC) Physician Rounds

At the completion of this section, the participant will:

• be familiar with the standard care of patient's with acute infarction, unstable angina, or who have undergone percutaneous coronary intervention
• be familiar with common procedures involved in the routine care of patients hospitalized for acute coronary intervention

Observe Open Heart Surgery*

At the completion of this section, the participant will:

• be familiar with common intraoperative care and procedures during cardiac surgery

Observe in Echocardiography Laboratory

At the completion of this section, the participant will:

• understand the indications for echocardiogram
• observe an echocardiogram

Observe in Stress Laboratory

At the completion of this section, the participant will:

• be familiar with various types of stress testing and their indications
• observe a stress test
• be familiar with the rationale for pre-testing instructions

* Participants will view open heart surgery based on surgical scheduling availability.

In order to most effectively meet the different needs of each of the participants, you will be requested to return the attached Needs Assessment Form appropriate to your background (research vs. non-research). This may assist us in the assignment of various breakout sessions.

Other information

• CE Units Available
• Small Classes - Only nine to 11 students per class; everyone receives the attention they need.
• Meals provided - Continental breakfast and lunch is provided on each day of the course

Attendees' comments

"I have been meaning to let you know that the CRA Cleveland Clinic Training was an incredible experience for me. The Nurse Specialists and other presenters really covered all the bases I needed to learn in order to be able to relate to my sites and cardiologists on a more clinical and professional level. Ellen McErlean (one of the speakers) and Jan Carlson (the overall course leader) were awesome! We actually got to round with the attending and residents in the CCU, while they presented cases and discussed all the available options and courses of treatment. Intellectually stimulating, and very cutting edge - This may sound naïve, but I have never seen a person being intubated before. Wow."
*Mary

"I truly valued the opportunity to engage in such a well-organized and thoughtfully planned program. Thank you for making it available to the CRAs."
*Sharon

"Excellent content and focus for CRAs. Extremely relevant to monitoring issues."
*Mark

*Denotes name change

To register:

Please print, complete and fax the following form no later than two weeks prior to your session to: Laura Konczos @ 216.445.9676

• Clinical Needs Assessment
• Non-Clinical Needs Assessment

For more information

This course is offered several times during the year and classes fill up quickly. To inquire about course dates and registration, please call Laura Konczos at 216.445.7006.

© Cleveland Clinic Foundation 9/05