INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure
NCT ID: NCT02787044
Last Updated: 2022-01-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
5388 participants
INTERVENTIONAL
2016-08-01
2020-05-31
Brief Summary
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Detailed Description
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Several lines of evidence suggest that a strategy of utilizing high-dose influenza vaccine in at risk cardiovascular patients would reduce morbidity and mortality. Immune responses to influenza vaccine, normally subject to variability by age and concomitant medical conditions, are substantially reduced in patients with heart failure evidenced by lower vaccine-induced antibody titers compared to healthy controls. In a randomized trial, antibody responses in patients with heart failure were augmented by using a higher dose of influenza vaccine. In a meta-analysis, higher dose influenza vaccination was associated with a 27% reduced risk for MACE compared to standard dose vaccine. A randomized study of high dose versus standard dose influenza vaccine in medically-stable patients over age 65 showed that participants receiving high dose vaccine had a 24% reduced risk of laboratory-confirmed influenza associated with protocol-defined influenza-like-illness, and had a low risk for adverse events. High dose influenza vaccine is FDA approved for use in medically stable adults over the age of 65, but has not been studied for patients under the age of 65 or in those with unstable, high risk medical conditions. The CDC does not preferentially recommend one influenza vaccine over another, and the optimal vaccine formulation that offers the most clinical protection in these high risk patients is unknown.
The high morbidity and health care costs among patients with high risk cardiovascular disease along with the reduced immune responses to standard dose influenza vaccines in patients with heart failure provides a compelling rationale to investigate alternative influenza vaccination strategies in this group. INVESTED is an outcomes study in patients with recent acute myocardial infarction (AMI) or heart failure (HF) to test whether a four-fold higher dose of trivalent influenza vaccine will reduce morbidity and mortality compared to standard dose quadrivalent vaccine. INVESTED will test the hypothesize that high dose vaccine will reduce the composite of all cause death or cardiopulmonary hospitalizations in this population, with the following specific aims:
Specific Aim 1. To test the hypothesis that high dose trivalent influenza vaccine will reduce the composite of death or cardiopulmonary events compared with standard dose quadrivalent influenza vaccine in high-risk cardiovascular patients. Patients with recent AMI or HF hospitalization will be randomized to high dose versus standard dose vaccine for up to three influenza seasons. The primary endpoint will be time to first occurrence of death or cardiopulmonary hospitalization within each influenza season. Hospitalizations will be ascertained utilizing multiple approaches (phone, patient report, and electronic health records). Key secondary outcome measures will include total (first and recurrent) cardiopulmonary hospitalizations or death, time to first occurrence of cardiovascular death or cardiopulmonary hospitalization, time to occurrence of all-cause death or cardiopulmonary hospitalization across all enrolled influenza seasons, time to occurrence of all-cause death, and time to first occurrence of cardiopulmonary hospitalizations.
Specific Aim 2. To test the hypothesis that antibody titers to influenza vaccine antigens are associated with cardiopulmonary outcomes. In a subset of participants, antibody titers by hemagglutination inhibition assays to influenza vaccine antigens at baseline and at 4 weeks following randomization will be determined, corresponding to achievement of maximal antibody titer levels after vaccination. The association between geometric mean titers post-vaccination and the occurrence of death or cardiopulmonary hospitalization (primary outcome measure of Specific Aim 1) will be assessed.
Other key correlative study (immune) outcome measures will include:
Change in antibody titers at 4 weeks post-vaccination from baseline to influenza vaccine antigens Seroconversion (demonstration of 4-fold rise in antibody concentrations from baseline) and seroprotection (demonstration of antibody titer level of 1:40) to A/H1N1, A/H3N2, and B-type vaccine antigens
The results of this trial have the potential to inform health care policy regarding optimal influenza vaccination for individuals with high risk cardiovascular disease, which may in turn reduce morbidity from this annual threat to health stability in patients with cardiovascular conditions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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High Dose Influenza Vaccine
High Dose Influenza Vaccine
High Dose Trivalent Influenza Vaccine
High Dose Trivalent Influenza Vaccine
Standard Dose Influenza Vaccine
Standard Dose Influenza Vaccine
Standard Dose Quadrivalent Influenza Vaccine
Standard Dose Quadrivalent Influenza Vaccine
Interventions
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High Dose Trivalent Influenza Vaccine
High Dose Trivalent Influenza Vaccine
Standard Dose Quadrivalent Influenza Vaccine
Standard Dose Quadrivalent Influenza Vaccine
Eligibility Criteria
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Inclusion Criteria
* history of hospitalization for myocardial infarction within 1 year of enrollment OR a history of hospitalization for heart failure within 2 years of enrollment
* At least one of the following additional risk factors:
* Prior MI (if HF the index event above; or a second MI)
* Prior HF hospitalization (if MI the index event above; or a second HF event)
* Age ≥ 65
* Left ventricular ejection fraction (LVEF) \< 40%
* Diabetes mellitus
* Obesity (BMI ≥ 30)
* Renal impairment (eGFR ≤ 60)
* History of ischemic stroke
* History of peripheral artery disease
* Current smoking
Exclusion Criteria
* Any non-cardiac condition that in the opinion of the investigator would lead to life expectancy less than 9 months.
* Receipt of influenza vaccine during current influenza season
* Any illness requiring treatment with antibiotics or anti-inflammatory medication within the past 14 days.
* Any fever over 100 degrees Fahrenheit or 38 degrees Celsius within the past 7 days.
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Wisconsin, Madison
OTHER
University of Toronto
OTHER
Boston VA Research Institute, Inc.
OTHER
Patient-Centered Outcomes Research Institute
OTHER
University of Minnesota
OTHER
Brigham and Women's Hospital
OTHER
Responsible Party
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Scott David Solomon
Professor of Medicine
Principal Investigators
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Orly Vardeny, PharmD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Scott D Solomon, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
KyungMann Kim, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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Birmingham VAMC
Birmingham, Alabama, United States
University of Alabama Hypertension Program
Birmingham, Alabama, United States
Heart Center Research, LLC
Huntsville, Alabama, United States
Alaska Heart & Vascular Institute
Anchorage, Alaska, United States
Banner University Medicine North
Tucson, Arizona, United States
University of Arizona- Sarver Heart Center
Tucson, Arizona, United States
CAVHS
Little Rock, Arkansas, United States
VA Loma Linda Healthcare System
Loma Linda, California, United States
Long Beach VAMC
Long Beach, California, United States
University of California Davis Medical Center
Sacramento, California, United States
VA San Diego Healthcare System
San Diego, California, United States
UCSF Medical Center
San Francisco, California, United States
VA West Haven
West Haven, Connecticut, United States
Washington DC VAMC
Washington D.C., District of Columbia, United States
Clearwater Cardiovascular Consultants
Clearwater, Florida, United States
N FL/S GA Veterans Health System
Gainesville, Florida, United States
OneFlorida CDRN
Gainesville, Florida, United States
Clearwater Cardiovascular Consultants-Largo
Largo, Florida, United States
Inpatient Research Corporation
Miami, Florida, United States
ITB Research
Miami, Florida, United States
Charlotte Heart Group Research Center
Port Charlotte, Florida, United States
Clearwater Cardiovascular Consultants-SH
Safety Harbor, Florida, United States
Bond Community Health Center, Inc.
Tallahassee, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Morehouse School of Medicine
Atlanta, Georgia, United States
Atlanta VA Health Care System
Decatur, Georgia, United States
Peidmont Fayette
Fayetteville, Georgia, United States
University of Hawaii
Honolulu, Hawaii, United States
Northwestern University
Chicago, Illinois, United States
Jesse Brown VA Medical Center
Chicago, Illinois, United States
University of Chicago Medicine
Chicago, Illinois, United States
Chicago Medical Research
Hazel Crest, Illinois, United States
Northwester Medicine Lake Forest
Lake Forest, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Captain James A. Lovell Federal Health Care Center
North Chicago, Illinois, United States
UnityPoint Health Methodist
Peoria, Illinois, United States
Central DuPage Hospital
Winfield, Illinois, United States
Krannert Institute of Cardiology
Indianapolis, Indiana, United States
St. Vincent Medical Group
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
VA Eastern Kansas Health Care System
Leavenworth, Kansas, United States
Robley Rex VA
Louisville, Kentucky, United States
The Heart Clinic of Hamond
Hammond, Louisiana, United States
Southeast Louisiana Veterans Healthcare System
New Orleans, Louisiana, United States
Ochsner Health System- Baton Rouge
New Orleans, Louisiana, United States
ENRM VA Hospital
Bedford, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Pentucket Medical Associates
Haverhill, Massachusetts, United States
Charles River Medical Associates
Natick, Massachusetts, United States
Boston/West Roxbury VA Hospital
West Roxbury, Massachusetts, United States
VA Boston Healthcase System
West Roxbury, Massachusetts, United States
VA Ann Harbor Healthcare System
Ann Arbor, Michigan, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
HealthPartners - Riverside Research
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
HealthEast Medical Research Institute
Saint Paul, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Kansas City VA Medical Center
Kansas City, Missouri, United States
VA St. Louis Health Care System
St Louis, Missouri, United States
St. Louis University
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Nebraska Heart Institute- Grand Island
Grand Island, Nebraska, United States
Darthmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cardio Assoc. of the Del. Valley- Elmer
Elmer, New Jersey, United States
Cardio. Assoc. of the Del. Valley- Haddon Heights
Haddon Heights, New Jersey, United States
Cardio. Assoc. of the Del. Valley- Sewell
Sewell, New Jersey, United States
Lourdes Cardiology Services
Voorhees Township, New Jersey, United States
New Mexico VA Health Care System
Albuquerque, New Mexico, United States
Albany Medical College
Albany, New York, United States
New York Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States
New York Presbyterian Queens Bayside/Whitestone
Flushing, New York, United States
New York Presbyterian/Queens
Flushing, New York, United States
NYPQ - Cardiology Outpatient Clinic
Flushing, New York, United States
Winthrop University Hospital
Mineola, New York, United States
New York VA
New York, New York, United States
NYU Langone Medical Center
New York, New York, United States
New York Presbyterian
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Charles George VA
Asheville, North Carolina, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke
Durham, North Carolina, United States
Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Heart House Research Foundation
Springfield, Ohio, United States
Oregon Health & Science
Portland, Oregon, United States
VA Portland Health Care Systems (VAPHCS)
Portland, Oregon, United States
Temple University
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Providence VA Medical Center
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
WJB Dorn VAMC
Columbia, South Carolina, United States
Palmetto Research Center, LLC
Spartanburg, South Carolina, United States
VAMC Memphis
Memphis, Tennessee, United States
Meharry Medical College
Nashville, Tennessee, United States
Tennessee Valley Healthcare Systems-Nashville
Nashville, Tennessee, United States
Vanderbilt University
Nashville, Tennessee, United States
Austin Heart- Heart Hospital
Austin, Texas, United States
Baylor Scott and White Heart and Vascular Hospital
Dallas, Texas, United States
Michael E. DeBakey VAMC, Houston
Houston, Texas, United States
Houston Heart & Vascular Associates
Kingwood, Texas, United States
Houston Methodist Research Institute-CCAT Pearland
Pearland, Texas, United States
St. David's Heath & Vascular PLLC
Round Rock, Texas, United States
South Texas Veterans Healthcare System
San Antonio, Texas, United States
STAR Clinical Trials
San Antonio, Texas, United States
Austin Heart San Marcos
San Marcos, Texas, United States
Baylor Scott and White Research Institute
Temple, Texas, United States
University of Utah
Salt Lake City, Utah, United States
George E. Wahlen Dept of VA Affairs Medical Center
Salt Lake City, Utah, United States
VA Medical Center White River Junction
White River Junction, Vermont, United States
Inova Heart and Vascular Institute
Alexandria, Virginia, United States
Carient Heart & Vascular
Manassas, Virginia, United States
Louis A Johnson VAMC
Clarksburg, West Virginia, United States
Gundersen Clinic
La Crosse, Wisconsin, United States
University of Wisconsin
Madison, Wisconsin, United States
Willam S. Middleton Memorial Veterans Hospital
Madison, Wisconsin, United States
University of Wisconsin Madison
Madison, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Aurora Research Institute, LLC
Milwaukee, Wisconsin, United States
Celement J. Zablocki VA Medical Center
Milwaukee, Wisconsin, United States
TotalCardiology
Calgary, Alberta, Canada
University of Calgary
Calgary, Alberta, Canada
CK Hui Heart Centre, Royal Alexandra Hospital
Edmonton, Alberta, Canada
Dr. MPJ Senaratne Professional Corporation
Edmonton, Alberta, Canada
Northwest Echocardiolography
Grande Prairie, Alberta, Canada
The CARe Clinic (Central Alberta Research)
Red Deer, Alberta, Canada
University of Alberta Hospital- Mazankoski Heart Institute
Edmonton, British Columbia, Canada
Kelowna General Hospital
Kelowna, British Columbia, Canada
SMH Cardiology Clinical
Surrey, British Columbia, Canada
Manna Research Inc. (Vancouver)
Vancouver, British Columbia, Canada
Vancouver General Hospital - Gordon Leslie Diamond Centre
Vancouver, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Victoria Heart Institute Foundation
Victoria, British Columbia, Canada
St. Boniface Hospital/University of Manitoba
Winnipeg, Manitoba, Canada
University of Sherbrooke
Dieppe, New Brunswick, Canada
G.A Research Associates Ltd.
Moncton, New Brunswick, Canada
QEII Health Sciences
Halifax, Nova Scotia, Canada
Brampton Research Assocaites
Brampton, Ontario, Canada
Manna Research Inc. (Burlington North)
Burlington, Ontario, Canada
Manna Research Inc. (Burlington South)
Burlington, Ontario, Canada
Cambridge Cardiac Care Center
Cambridge, Ontario, Canada
Vizel Cardiac Research
Cambridge, Ontario, Canada
Dr. Alan David Bell
Downsview, Ontario, Canada
Health Sciences North Research Institute
Greater Sudbury, Ontario, Canada
Dr. D. Shukla Professional Medicine Corporation
Greater Sudbury, Ontario, Canada
Dr. R. Labonte Professional Medicine Corporation
Greater Sudbury, Ontario, Canada
Hamilton Health Sciences General Hospital/ McMaste
Hamilton, Ontario, Canada
Queen's University CardioPulmonary Unit
Kingston, Ontario, Canada
St. Joseph's Health Care
London, Ontario, Canada
Dixie Medical Group
Mississauga, Ontario, Canada
Apple Hills Medical Associates
Mississauga, Ontario, Canada
PACE
Newmarket, Ontario, Canada
North York General Hospital
North York, Ontario, Canada
Sewa Ram Singal Med Prof Corporation
North York, Ontario, Canada
Heart Care Research
Oshawa, Ontario, Canada
Dr. James Cha
Oshawa, Ontario, Canada
Montfort Hospital and Ottawa Cardiovascular Centre
Ottawa, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Heart Function Clinic Queensway Carleton
Ottawa, Ontario, Canada
Kawartha Cardiology
Peterborough, Ontario, Canada
St. Catherines Hospital
Saint Catherines, Ontario, Canada
Scarborough General Hospital
Scarborough Village, Ontario, Canada
Manna Research (Stoney Creek)
Stoney Creek, Ontario, Canada
Thunder Bay Regional Health Sciences Center
Thunder Bay, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Women's College Hospital
Toronto, Ontario, Canada
University of Toronto
Toronto, Ontario, Canada
iHealthCentre
Vaughan, Ontario, Canada
CISSS de Laval, Hopital Cite de la Sante
Laval, Quebec, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
CIUSSS NÎM Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Manna Research Inc. (Montreal)
Montreal, Quebec, Canada
IUCPQ
Québec, Quebec, Canada
Centre hospitalier régional de Lanaudière
Saint-Charles-Borromée, Quebec, Canada
CISSSI- Hopital Pierre-Le Gardeur
Terrebonne, Quebec, Canada
Centre Hospitalier de Regional Trois-Rivieres
Trois-Rivières, Quebec, Canada
Prairie Vascular Research Inc.
Regina, Saskatchewan, Canada
VA Caribbean Healthcare System
San Juan, , Puerto Rico
Countries
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References
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Vardeny O, Sweitzer NK, Detry MA, Moran JM, Johnson MR, Hayney MS. Decreased immune responses to influenza vaccination in patients with heart failure. J Card Fail. 2009 May;15(4):368-73. doi: 10.1016/j.cardfail.2008.11.009. Epub 2008 Dec 18.
Vardeny O, Moran JJ, Sweitzer NK, Johnson MR, Hayney MS. Decreased T-cell responses to influenza vaccination in patients with heart failure. Pharmacotherapy. 2010 Jan;30(1):10-6. doi: 10.1592/phco.30.1.10.
Van Ermen A, Hermanson MP, Moran JM, Sweitzer NK, Johnson MR, Vardeny O. Double dose vs. standard dose influenza vaccination in patients with heart failure: a pilot study. Eur J Heart Fail. 2013 May;15(5):560-4. doi: 10.1093/eurjhf/hfs207. Epub 2013 Jan 4.
Albrecht CM, Sweitzer NK, Johnson MR, Vardeny O. Lack of persistence of influenza vaccine antibody titers in patients with heart failure. J Card Fail. 2014 Feb;20(2):105-9. doi: 10.1016/j.cardfail.2013.12.008. Epub 2013 Dec 19.
Udell JA, Farkouh ME, Solomon SD, Vardeny O. Does influenza vaccination influence cardiovascular complications? Expert Rev Cardiovasc Ther. 2015 Jun;13(6):593-6. doi: 10.1586/14779072.2015.1044439. Epub 2015 May 14.
Vardeny O, Claggett B, Udell JA, Packer M, Zile M, Rouleau J, Swedberg K, Desai AS, Lefkowitz M, Shi V, McMurray JJV, Solomon SD; PARADIGM-HF Investigators. Influenza Vaccination in Patients With Chronic Heart Failure: The PARADIGM-HF Trial. JACC Heart Fail. 2016 Feb;4(2):152-158. doi: 10.1016/j.jchf.2015.10.012. Epub 2015 Dec 30.
Udell JA, Zawi R, Bhatt DL, Keshtkar-Jahromi M, Gaughran F, Phrommintikul A, Ciszewski A, Vakili H, Hoffman EB, Farkouh ME, Cannon CP. Association between influenza vaccination and cardiovascular outcomes in high-risk patients: a meta-analysis. JAMA. 2013 Oct 23;310(16):1711-20. doi: 10.1001/jama.2013.279206.
Vardeny O, Udell JA, Joseph J, Farkouh ME, Hernandez AF, McGeer AJ, Talbot HK, Bhatt DL, Cannon CP, Goodman SG, Anand I, DeMets DL, Temte J, Wittes J, Nichol K, Yancy CW, Gaziano JM, Cooper LS, Kim K, Solomon SD. High-dose influenza vaccine to reduce clinical outcomes in high-risk cardiovascular patients: Rationale and design of the INVESTED trial. Am Heart J. 2018 Aug;202:97-103. doi: 10.1016/j.ahj.2018.05.007. Epub 2018 May 23.
Vardeny O, Kim K, Udell JA, Joseph J, Desai AS, Farkouh ME, Hegde SM, Hernandez AF, McGeer A, Talbot HK, Anand I, Bhatt DL, Cannon CP, DeMets D, Gaziano JM, Goodman SG, Nichol K, Tattersall MC, Temte JL, Wittes J, Yancy C, Claggett B, Chen Y, Mao L, Havighurst TC, Cooper LS, Solomon SD; INVESTED Committees and Investigators. Effect of High-Dose Trivalent vs Standard-Dose Quadrivalent Influenza Vaccine on Mortality or Cardiopulmonary Hospitalization in Patients With High-risk Cardiovascular Disease: A Randomized Clinical Trial. JAMA. 2021 Jan 5;325(1):39-49. doi: 10.1001/jama.2020.23649.
Lassen MCH, Howell N, Claggett BL, Biering-Sorensen T, Vardeny O, Solomon SD, Udell J, Joseph J, Hegde SM. Educational Attainment Level and Risk of Mortality and Cardiopulmonary Outcomes in High-Risk Patients With Cardiovascular Disease: The INVESTED Trial. J Am Heart Assoc. 2025 Jul;14(13):e040221. doi: 10.1161/JAHA.124.040221. Epub 2025 Jun 18.
Peikert A, Claggett BL, Udell JA, Joseph J, Hegde SM, Kim K, Mao L, Wang T, Havighurst TC, Farkouh ME, Bhatt DL, Tattersall MC, Cooper LS, Solomon SD, Vardeny O. Influenza Vaccine Immune Response in Patients With High-Risk Cardiovascular Disease: A Secondary Analysis of the INVESTED Randomized Clinical Trial. JAMA Cardiol. 2024 Jun 1;9(6):574-581. doi: 10.1001/jamacardio.2024.0468.
Hegde SM, Claggett BL, Udell JA, Kim K, Joseph J, Farkouh ME, Peikert A, Bhatt AS, Tattersall MC, Bhatt DL, Cooper LS, Solomon SD, Vardeny O. Temporal Association Among Influenza-Like Illness, Cardiovascular Events, and Vaccine Dose in Patients With High-Risk Cardiovascular Disease: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2331284. doi: 10.1001/jamanetworkopen.2023.31284.
Wang T, Mao L. Stratified proportional win-fractions regression analysis. Stat Med. 2022 Nov 20;41(26):5305-5318. doi: 10.1002/sim.9570. Epub 2022 Sep 14.
Vardeny O, Hernandez AF, Cohen LW, Franklin A, Baqai M, Palmer S, Bierer BE, Cobb N. Transitioning to the National Institutes of Health single institutional review board model: Piloting the use of the Streamlined, Multi-site, Accelerated Resources for Trials IRB Reliance. Clin Trials. 2019 Jun;16(3):290-296. doi: 10.1177/1740774519832911. Epub 2019 Mar 13.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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INVESTED Trial Website
Other Identifiers
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2015P001823
Identifier Type: -
Identifier Source: org_study_id
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