Current Clinical Trials

• RESPECT: The Randomised Evaluation of Stroke comparing PFO closure to Establised Current Standard of Care Treatment Trial.

  Principal Investigator: Richard Smalling, M.D., Ph.D.
  IRB Approval Number: HSC-MS-02-186

  Study Description:
  Patent foramen Ovale (PFO) is one potential suspected cause of cryptogenic stroke. Cryptogenic stroke is a stroke that occurs without normal symptoms associated with stroke. It is not known what the best treatment is to reduce the risk of a recurrent stroke. AGA Medical Corporation is conducting the RESPECT Trial to investigate whether percutaneous closure of PFO using Amplatzer PFO occluder is superior to current standard medical management in preventing recurrent cryptogenic strokes or TIA.

  The study is a randomized, multi-center active control trial. Patients will be randomized to either receive the AMPLATZER PFO Occluder plus medical therapy or be treated with the current medical therapy standard of care.

  Study Population:
  Patients with PFO who have had a cryptogenic stroke within the last 270 days, with stroke defined as follows: acute focal neurological deficit, presumed to be due to focal ischemia, and either 1) symptoms persisting 24 hours or greater, or 2) symptoms persisting less than 24 hours but associated with MR or CT findings of a new, neuroanatomically relevant, cerebral infarct.

  Cryptogenic stroke is defined as a stroke from an unknown cause.
  PFO is defined as visualization of microbubbles per TEE in the left atrium within three cardiac

  Study Coordinator:
  Truc Baccam, R.N., 713.500.5214

  ---

• IMPACT: The Impact of BIOTRONIK Home Monitoring Guided Anticoagulation on Stroke Risk in Patients with Implanted ICD and CRT-D devices

  Principal Investigator: Bharat Kantharia, M.D.
  IRB Approval Number: HSC-MS-08-0530

  Study Description:
  Prospective, multicenter, single-blinded, and randomized (1:1 ratio) trial. This study will investigate the clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) technology and a predefined anticoagulation plan compared to conventional device evaluation and physician-directed anticoagulation in patients with implanted dual-chamber defibrillators or cardiac resynchronization devices

  Study Population:
  Patients implanted with a BIOTRONIK Lumax HF-T / DR-T device or future legally marketed BIOTRONIK dual chamber ICD or CRT-D with HM and IEGM-Online technology and with a CHADS2 of 1 or higher.

  Patients in permanent AF or following anticoagulation therapy for any reason are excluded from participation.

  Funding Source/Agency:
  BIOTRONIK, Inc.

  Study Coordinator:
  Sherry Sterling R.N., CCRC, 713.500.6598

  ---

• SAPPHIRE WW: Stenting and Angioplasty with Protection in Patients at HIgh-Risk for Endarterectomy

  Principal Investigator: Richard Smalling, M.D., Ph.D.
  IRB Approval Number: HSC-MS-06-0497

  Study Description:
  The primary objective of this multi-center, prospective, observational study is to estimate 30-day MAE rate of stenting (any death, stroke or any MI) with distal protection in the treatment of obstructive carotid artery disease in high-surgical risk patients with atherosclerotic disease of the carotid artery(ies). The devices to be utilized are the Cordis PRECISEÒ Nitinol Stent Systems, the Cordis ANGIOGUARD™ XP/RX Emboli Capture Guidewire (ECGW) and next generation Cordis carotid stents and EPDs as they become commercially available. The secondary objectives are to assess the consistency of 30-day MAE rates of stenting with distal protection in the treatment of obstructive carotid artery disease at high, medium and low volume center with physicians who have validated CASES training levels of 1, 2, 2P or 3 (see appendix C) and to estimate 360-day MAE (death and ipsilateral stroke) rate.

  Study Population:
  The study population will consist of high-surgical risk patients with atherosclerotic disease of the carotid artery(ies). There will be up to 350 clinical sites from the US, Canada, Latin America, Europe and Asia Pacific participating in this study, enrolling up to 10,000 patients. There will be centers included that perform low, medium and high annual carotid stent implant volumes, from both academic and private hospitals, and across geographic locations. Consented high surgical risk patients, treated as per the IFU labeling, will be enrolled.

  Funding Source/Agency:
  Cordis, a Johnson&Johnson company

  Study Coordinator:
  Rhonda Patterson, R.N., B.S.N., 713.500.6550

  ---

• VEST/PREDICTS: Vest prevention of Early Sudden death Trial (VEST) and PREDiction of ICD Therapies Study (PREDICTS)

  Principal Investigator: Anne Dougherty, M.D.
  IRB Approval Number: HSC-MS-08-0367

  Study Description:
  While implantable cardioverter-defibrillators (ICDs) have had some impact in reducing the nearly 500,000 annual sudden cardiac deaths (SCD) in the US, our current treatment strategy is still limited. Recent studies have demonstrated a very high rate of sudden cardiac death in the first 2 months following a myocardial infarction (MI), particularly in participants with depressed left ventricular function. Nonetheless, because no study to date has demonstrated a mortality benefit of implanting an ICD within 40 days immediately after MI, the current practice is to wait at least 40 days after an MI. This leaves an unprotected, vulnerable period of increased sudden death risk prior to ICD implantation. Therefore, two deficiencies in our current treatment strategy are:

  1. the untreated high sudden death rate in the early post-MI period, and
  2. the non-specific nature of EF to predict spontaneous ventricular arrhythmias and ICD shocks.

  To address these important deficiencies, we have designed the VEST and PREDICTS studies, which will be performed in a single prospective cohort with the Specific Aims stated as follows:

  1. To conduct a multicenter, randomized controlled trial to test the hypothesis that a non-invasive wearable automatic defibrillator vest will reduce overall mortality in the first 60 days following an MI in participants with left ventricular dysfunction (EF≤35%).
  2. To develop and validate a multivariable risk stratification tool that predicts the occurrence of spontaneous fast ventricular arrhythmias that would result in ICD shocks during the 5 years after MI, and efficiently identifies very high-risk participants in whom an implantable cardioverter-defibrillator (ICD) would be most cost-effective, as well as very low-risk participants in whom it is not needed.
  3. To establish a repository of DNA, serum, Holter recordings, echocardiograms, ECGs and other risk stratification data in a large cohort of participants followed prospectively for arrhythmic outcomes.

  Study Population:
  Participants hospitalized with an MI with left ventricular ejection fraction (LVEF) of <35% who are at least 18 years old

  Study Duration:
  VEST: 60 days
  PREDICTS: 5 years (average); minimum 3 years

  Funding Source/Agency:
  NIH/NHLBI, U01HL089458 and U01HL089145
  Medtronic, A108521
  ZOLL-Lifecor, A108523
  GE, A108526

  Study Coordinator:
  Sherry Sterling R.N., CCRC, 713.500.6598

  ---

• HEARTS: Houston Early Age Risk Testing & Screening

  Principal Investigator: John Higgins, M.D.
  IRB Approval Number: HSC-MS-08-0518

  Study Description:
  Sudden cardiac arrest (SCA) occurs in ~ 1/100,000 students/year. Following SCA, 90% die; of the remainder, 33% have permanent neurological damage. Automated External Defibrillators (AED’s) help prevent death if SCA occurs & are mandated in Texas schools. We estimate that~ 1:50-1:100 young children in US have an undiagnosed heart condition. Family doctors were unaware of any underlying cardiac abnormality in >=95% of children who die suddenly i.e. screening by history & physical examination alone are not sufficient to detect many critical cardiovascular abnormalities in young children. There is no standard screening of school or college athletes, nor are there approved certification procedures for professionals who perform screening examinations. In Italy, since the introduction of a nationwide systematic cardiovascular screening, the incidence of SCA in young competitive athletes has substantially declined when compared to unscreened non-athletes. By identifying sixth grade students with cardiac conditions associated with SCA, we aim to prevent their having SCA via correct treatment of their condition and appropriate exercise limitations. In addition, knowledge of their diagnosis allows them to change their life focus.

  Study Objective:
  This Study aims to develop an effective and cost-efficient program whereby 1500 sixth grade students in schools in the city of Houston are administered cardiovascular screening which will include a (1) selfadministered questionnaire, (2) cardiac physical examination, (3) electrocardiogram (EKG), and a (4) limited 2-dimensional and Doppler echocardiogram (2-D echo) in a time efficient manner by trained and licensed healthcare workers. The data collected through this study will be analyzed to determine the sensitivity and specificity of each of these four components of the screening test.

  Study Duration:
  VEST: 60 days
  PREDICTS: 5 years (average); minimum 3 years

  Funding Source/Agency:
  Memorial Hermann Foundation

  Study Coordinator:
  HEARTS-study@uth.tmc.edu, 1.866.987.7934

  ---