Published on January 20, 2009
Starts February 14, 2009 Valentine’s Day A Randomized Trial Of Integrated CAD Management By Cardiac PET Imaging, Meds To Goals & Lifestyle Weatherhead Center for Preventing and Reversing Atherosclerosis Stefano Sdringola MD, Weatherhead Distinguished Chair in Heart Disease and K. Lance Gould MD, Bucksbaum Distinguished University Chair in Cardiovascular Medicine, University of Texas Medical School
Patients with “Appropriate” indication for Stress SPECT imaging Randomization Strategy A: SPECT guided + Standard Therapy Strategy B: PET guided + Comprehensive Therapy Coronary arteriogram, PCI or Strategy A Strategy B CAB decided by referring MD PET scan -no report from PET/SPECT or Century PET scan + Report cardiologists if requested Goal: lean, exercise, All medical Rx by Follow-up PET at LDL≤70,HDL>45, referring MD with no TG<100, BP & BS 24 months (blinded) management f/u by controlled, ASA, Century staff, beta blockers, close no PET report f/u, motivation, PET Clinical Follow-up for 5 years to MD or patient report to MD & and final Follow-up PET at year 5 reviewed with pt
Referring MD Options For PET Guided Strategy B Group Select One 1. Century staff provides your patient lifestyle support by regular visits to Century clinic with reports to you and suggestions to you for potential medication changes to achieve AHA goals for you to implement if appropriate. You decide on all interventions. 2. Century staff provides your patient lifestyle support by regular visits to Century clinic and also manages lipid or other medications as needed to achieve AHA goals with updates reported to you. You decide on all interventions. 3. Century staff provides your patient lifestyle support by regular visits to Century clinic, manages lipid or other medications as needed to achieve AHA goals with updates reported to you. Century cardiologists decide on invasive cardiac interventions, or not, as a consultative and management service for coronary artery disease reported to you.
Inclusion Criteria Suspected CAD DM and ≥ 2 RF No DM Symptomatic Asymptomatic Women ≥ 50 yrs ≥50 yrs Coronary Men and ≥2 RF and ≥ 2 RF Calcification ≥3 RF
Inclusion Criteria Documented CAD by cath, SPECT, MI No previous PCI/CABG revascularization Asymptomatic or Asymptomatic Worsening Any Stable Symptoms Post CABG ≥ 5 yrs Symptoms Symptoms Dx of CAD > 1 yr Post PCI ≥ 2 yrs
Century Exclusion Criteria •Age <40 years old. • Low pretest likelihood of CAD. • Unstable or severe heart disease, CAB/PCI in prior 6 months, EF <30%. • Major co-morbidities, renal or liver dysfunction, severe HTN, adverse social conditions, unable to exercise. • Morbid Obesity defined by Body Mass Index > 35. • Stable or asymptomatic CAD diagnosed within one year previously. • Concurrent other research studies using investigational drugs/devices.
Study Referral Steps Patient is referred for SPECT** Referring MD contacts Century Staff Century hotline 713-500-5200 Century Study pager 281-314-0228 Century staff: 1. Arrives in referring physician’s clinic to screen patient and/or 2. Receives referring physician’s permission to call patient 3. Presents study to patient, if eligible 4. Arranges to meet patient at SPECT stress test & informed consent Referring MD receives: 1. Notification of patient’s group assignment 2. Reports with assessments & recommendations **Study enrollment and initial research PET scan must be within 2 weeks of SPECT
Principal Investigator Co-Principal Investigator Stefano Sdringola, MD K. Lance Gould, MD Office: 713-500-6576 Office: 713-500-6611 Pager: 713-704-7243 x24869 Pager: 713-704-7243 x24963 Email: Stefano.Sdringola@uth.tmc.edu Email: K.LanceGould@uth.tmc.edu Study Coordinator Study Coordinator Catey V. Carter, RN, CCRC Mary Haynie, RN, MBA Office: 713-704-2484 Phone: 713-500-6611 Cell: 713-628-5017 Fax: 713-500-6615 Fax: 713-500-6615 Pager: 281-314-0236 Email: Mary.P.Haynie@uth.tmc.edu Pager: 281-314-0228 Email: Catharine.V.Carter@uth.tmc.edu CRU Nurse Manager CRU Primary Nurse Kathy Franco, RN Erica Pena-Thompson, RN Office: 713-704-4171 Office: 713-704-4137 Fax: 713-704-6417 Fax: 713-704-6147 Email: Kathy.D.Franco@uth.tmc.edu Email: Erica.Pena-Thompson@uth.tmc.edu Study Coordinators: PET Scheduling CRU Scheduling Susan Hood Josephine Turner Office: 713-500-6611 x2 Phone: 713-704-4137 Catey Carter, RN and Fax: 713-500-6615 ŹFax: 713-704-6417 Email: Susan.M.Hood@uth.tmc.edu Email: firstname.lastname@example.org Mary Haynie, RN, MBA Dietitian Dietitian Patricia Mendoza, MS, RD, LD Marilyn Edwards, PhD, RD, LD Office: 713-704-5115 Office: 713-500-6677 Fax: 713-704-6417 Fax: 713-500-6699 Email: Patricia.M.Mendoza@uth.tmc.edu Email: Marilyn.S.Edwards@uth.tmc.edu Epidemiologist / Biostatistician Randomization IT Specialist Deborah del Junco, PhD Jeremy Russell Office: 713-500-7902 Office: 713-500-3917 Email: Deborah.J.DelJunco@uth.tmc.edu Email: Jeremy.Russell@uth.tmc.edu Economic/ Quality of Life Analysis Economic/ Quality of Life Analysis James Langabeer, MBA, CMA, EdD David Lairson, PhD Office: 713-500-9190 Office: 713-500-9176 Fax: 713-500-9171 Email: David.R.Lairson@uth.tmc.edu Email: James.R.Langabeer@uth.tmc.edu Economic/ Quality of Life Analysis SPECT Core Lab James Mahmarian, MD Zhen ŅJ uneÓZhang Maria Frias, assistant Office: 713-500-9850 Office: 713-441-2849 Cell: 713-408-8581 Fax: 713-793-7034 Fax: 713-500-9171. Email: email@example.com, MEFrias@tmhs.org Email: firstname.lastname@example.org CRU Laboratory Services PET Core Lab K. Lance Gould, MD Monika Ruscheinsky, M.S. Stefano Sdringola, MD Office: 713-704-4137 Catalin Loghin, MD Fax: 713-704-6147 Nils Johnson, MD Email: email@example.com CRU Nurses Clinic Physicians Amy Dodd, RN Stefano Sdringola, MD Office: 713-704-4137 Pager: 713-704-7243 x 24869 Email: Amy.Dodd@uth.tmc.edu Theresa Dancsak, RN Emma Cid, MD Office: 713-704-4137 Pager: 713-318-0234 Email: Theresa.Dancsak@uth.tmc.edu
Starts February 14, 2009 Valentine’s Day www.centuryhealthstudy.org • Century Study hotline: 713-500-5200 • Century Study pager: 281-314-0228 • Weatherhead PET Center: 713-500-6611 • Stefano Sdringola, MD pager: 713-704-7243 x24869
Century Health Study (713) 500-5200 Hotline (713) 704-2695 Fax firstname.lastname@example.org 6411 Fannin Street Ground Floor, HG 009 Houston, Texas 77030
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