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Community Consultation for the Proposed Chest Pain Study

Community Consultation for the Proposed Chest Pain Study. DATE: September 7, 2006 LOCATION: Italian Community Center Milwaukee, WI PRESENTER: Tom P. Aufderheide MD, FACEP Professor of Emergency Medicine Froedtert Memorial Lutheran Hospital Medical College of Wisconsin.

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Community Consultation for the Proposed Chest Pain Study

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  1. Community Consultation for the Proposed Chest Pain Study DATE: September 7, 2006 LOCATION: Italian Community Center Milwaukee, WI PRESENTER: Tom P. Aufderheide MD, FACEP Professor of Emergency Medicine Froedtert Memorial Lutheran Hospital Medical College of Wisconsin

  2. NIH Disclaimer This study is supported by the National Institutes of Health, National Heart, Lung and Blood Institute, Department of Health and Human Services. Its contents are solely the responsibility of the investigators and do not necessarily represent the official views of the National Heart, Lung and Blood Institute.

  3. Introductions • Institutions Research Board (IRB) Representatives • Principal Investigator Tom P. Aufderheide, MD, Medical College WI • Study Funding National Heart, Lung and Blood Institute (NHLBI) • Sponsor of the study Center for Cardiovascular Health Services Research at Tufts-New England Medical Center

  4. 7:00 pm -- 7:20 pm 7:20 pm – 9:00 pm IMMEDIATE Trial Research Presentation Community Consultation & Discussion Agenda

  5. Background In the United States each year, there are… • 1.2 million heart attacks • 1.8 million unstable angina episodes • 500,000 deaths: 300,000 out of hospital, 200,000 in hospital

  6. Early GIK? Dextrose in Army “K Rations” (Advertisement c. 1945 LIFE Magazine) IMMEDIATE Trial aims to translate into clinical practice 40+ years of work on GIK for cardiac protection.

  7. Preliminary Research • Human Studies using Glucose-Insulin-Potassium (GIK) • Given too late to preserve heart muscle • IMMEDIATE Trial • Treatment (GIK) will be started at the earliest possible moment (in the ambulance)

  8. Why are we doing this study? • Early recognition and treatment of heart attack symptoms is very important. • To determine if an intravenous “GIK” solution of glucose, insulin, and potassium can reduce the likelihood of death from heart attack. • To test whether GIK can prevent threatening heart attacks from occurring, and for heart attacks already underway, whether GIK can decrease serious complications and death. • To test the use of GIK at the earliest possible time (in the ambulance) in the treatment of threatened or established heart attack; This is the time of highest risk of death and therefore, greatest opportunity for saving lives.

  9. What is the study? • Multi-center (nationwide) • Wisconsin • Massachusetts • Texas • Placebo-controlled (GIK or standard IV solution) • Randomized study (50-50 chance of receiving GIK) • Double-blind (neither patient, paramedics, or doctor will know which solution the patient is receiving)

  10. Randomization Subjects will have: • 1/2 chance of receiving standard IV of sugar water • 1/2 chance of receiving GIK

  11. Whatis the study drug? Patients will receive either GIK or the Placebo. GIK • Glucose: Sugar-energy source for body-provides fuel to the heart when there is a reduced blood supply. • Insulin: Hormone, made naturally by the body-moves glucose into the cells. • Potassium: Salt, found in many foods and stored in the blood. Essential to maintain adequate levels. Placebo • Standard IV solution of sugar and water.

  12. Who will be in the study? Potential participants must meet all of the following conditions: • 30 years of age or older • Call 9-1-1 and treated by Milwaukee County paramedics • Have symptoms of a heart attack such as chest pain or pressure, difficulty breathing, sweating or nausea. • Have positive findings on an electrocardiogram (ECG performed by paramedics in the ambulance) that indicates a heart attack or lack of blood supply to the heart • Paramedic believes that the patient is very likely to be having a heart attack or lack of blood supply to the heart

  13. Who will not be in the study? • Less than 30 years of age • Unconscious or unable to communicate • Unable or unwilling to comply with study • Undergoing dialysis for kidney disease • Lungs congested with fluid • Medical condition unstable, such as low blood pressure • A prisoner • Woman known to be pregnant

  14. What does the study involve? • All patients who meet entry criteria and have symptoms of a threatened or established heart attack that call 9-1-1 could be enrolled in the study. • A 12-lead ECG or electrocardiogram will be acquired by paramedics to help determine if the patient is having a heart attack. • If the patient is eligible for the study, paramedics will inform the patient about the study and ask if they want to participate. If the patient is willing to participate… • GIK or Placebo will be started by the paramedic in the ambulance. • Emergency department (ED) physicians will confirm diagnosis. • Out-of-hospital and in-hospital treatment is otherwise unchanged. • GIK or Placebo will continue for 12 hours. • Research personnel will contact patient three times after hospital discharge.

  15. How will a patient be enrolled? Paramedics will read a disclosure information card to the patient (and/or family member if available) about the study. Patients may be aware of the study as a result of the public notification process. However, there will be some patients who will not have heard of the study. This disclosure will act as reminder to patients who are already aware of the study and as information and notification of the study to those patients who are unaware of the study. Patient may tell the paramedic that he or she does not want to participate (decline) before the Study Drug is started. After arrival at the ED, Informed Consent will be obtained. Patient can withdraw at anytime by telling the medical staff. There will be no disruption in care.

  16. Study Protocol Patient meets entry criteria Agrees to participate Placebo GIK Out-of-hospital and in-hospital treatment by standard of care Out-of-hospital and in-hospital treatment by standard of care Outcome Outcome

  17. Study Protocol Continued • Financial benefits: none • Alternative procedures: none • Confidentiality • Information will remain confidential • Access to medical records Food and Drug Administration (FDA) Study drug sponsor (Tufts-NEMC) National Institutes of Health (NIH) Participating Hospital Institutional Review Boards (IRB) Members of the research team

  18. Safety Monitoring Data and Safety Monitoring Board: Monitor differences in • Adverse events • Survival rates

  19. Differences Between Treatment and Research • Treatment • Proven to be effective • Established as acceptable practice • Involves risks and benefits • Research • Attempts to advance knowledge and improve treatment • Unproven (experimental) intervention • Randomize • Involves risks and benefits

  20. What are the potential benefits of GIK? • Might increase the likelihood of survival • May decrease or slow the damage to the heart • May allow other treatments to have a better chance of working • May reduce the likelihood of congestive heart failure following a heart attack

  21. What are the risks? Death from a heart attack or lack of blood supply to the heart is a risk regardless of participation in the study • Unknown or unanticipated risk • Redness, soreness or inflammation at the IV site. • Change in potassium level (high or low) which may cause palpitations (heart is beating fast) or dizziness. • Change in blood sugar levels (high or low) that could cause weakness, dizziness or thirstiness. • Increased fluid in lungs. from 12 hours of IV solution. In very few people, (Less than 1 out of 1,000 subjects with a heart attack treated with GIK) medication is necessary to get rid of extra fluid. • Loss of confidentiality related to medical records review. • Anxiety related to follow-up questionnaires/testing procedures.

  22. Study Duration & Timeline Plans for Enrollment • Study Start: Summer 2006 • Study Duration: ~ 28 months • 24 hours a day / 7 days a week • ~ 60,000 patients will be screened nationwide, 12,000 locally • 15,450 patients will be enrolled nationwide, 3,000 locally

  23. Study Approval Study will not proceed without final approval from: • Local Institutions Research Boards (IRB) • Investigational New Drug (IND) exemption from the Food and Drug Administration

  24. Why are we all here? Enrollment in the IMMEDIATE Trial is being performed under emergency circumstances. Patients may not be physically or emotionally able to understand the study and make an informed decision to participate. In order for GIK to have the highest likelihood to benefit the patient, it must be initiated as soon as possible after the onset of symptoms. Therefore the FDA has required that the process of exception to informed consent under emergency circumstances be implemented for the out-of-hospital or paramedic phase of the study.

  25. Exception from Informed Consent Requirements for Emergency Research • Informed Consent • Exception issued by Food and Drug Administration (FDA) • Exception to informed consent under emergency circumstances

  26. Food and Drug Administration (FDA) Requirements for Exception to Informed Consent A. IRB with concurring physician finds and documents 1. Life threatening situation with unproven or unsatisfactory treatment and research is necessary 2. Obtaining informed consent is not feasible 3. Participation in research has prospect of direct benefit because i. Situation necessitates intervention ii. Science supports potential of direct benefit iii. Risks are reasonable compared to medical condition 4. Research could not practicably be done without waiver 5. Potential therapeutic window is short 6. IRB approves consent document and procedures for subject or legal representative

  27. Food and Drug Administration (FDA) Requirements for Exception to Informed Consent (Continued) B. Information provided to subject, legal representative, and/or family as soon as possible C. Documentation will be kept on file in accordance with IRB regulations D. Separate investigational new drug (IND) exemption obtained from FDA E. Additional protections i. Public disclosure prior to initiation ii. Public disclosure after completion iii. Independent Data and Safety Monitoring Board iv. Attempt to contact family member when possible v. Community consultation

  28. For more information please contact: Tom P. Aufderheide MD, FACEP Department of Emergency Medicine 9200 West Wisconsin Avenue, Froedtert East Milwaukee, Wisconsin 53226 Office: (414) 805-2572 Fax: (414) 805-6532 Email: taufderh@mcw.edu www.IMMEDIATETrial.com

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