IMPRoving Outcomes in Vascular DisEase - Aortic Dissection (IMPROVE-AD)

April 28, 2026 updated by: Duke University

IMPRoving Outcomes in Vascular DisEase- Aortic Dissection

The goal of this clinical trial is to determine whether an upfront invasive strategy of TEVAR plus medical therapy reduces the occurrence of a composite endpoint of all-cause death or major aortic complications compared to an upfront conservative strategy of medical therapy with surveillance for deterioration in patients with uncomplicated type B aortic dissection.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will be a prospective, pragmatic, randomized clinical trial of the comparative effectiveness of an initial strategy for the treatment of uncomplicated type B aortic dissection (uTBAD). Patients with uTBAD and no prior history of aortic intervention will be randomized within 48 hours to 6 weeks after index admission to one of the two initial strategies. Follow-up will be ascertained via a centralized call center and ascertainment of medical records, as well as remote blood pressure monitoring. Recommendations regarding medical therapy will be made to enrolling centers and feedback on the quality of medical care given, however, all subsequent care, with the exception of aortic interventions, will be at the discretion of the responsible clinical care team. Aortic interventions will allowable only as per protocol.

Study Type

Interventional

Enrollment (Estimated)

1100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X 0C1
        • Recruiting
        • CHUM - Centre hospitalier de l'Université de Montréal
        • Contact:
          • Benjamin Orcese
          • Phone Number: 30988 514-890-8000
        • Principal Investigator:
          • Laura Drudi, MD
      • Montreal, Quebec, Canada, H3A 0G4
        • Recruiting
        • McGill University Medical Center
        • Contact:
          • Hila Tabrizian
          • Phone Number: 514-718-5025
        • Principal Investigator:
          • Robert James Doonan, MD
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
        • Principal Investigator:
          • Adam Beck, MD
        • Contact:
          • Adam Beck, MD
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • Recruiting
        • HonorHealth
        • Principal Investigator:
          • Hasan Aldailami, MD
        • Contact:
          • General Office Number
          • Phone Number: 480-323-1046
    • California
      • Long Beach, California, United States, 90806
        • Recruiting
        • Memorial Care Long Beach Medical Center
        • Contact:
          • Rodney White, MD
        • Principal Investigator:
          • Rodney White, MD
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Keck Medical Center of USC
        • Contact:
          • Alyssa Pyun, MD
        • Principal Investigator:
          • Alyssa Pyun, MD
      • San Diego, California, United States, 92110
        • Withdrawn
        • University Of California San Diego
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California
        • Contact:
          • Alexis Callanta
          • Phone Number: 415-353-4368
        • Principal Investigator:
          • Jade Hiramoto, MD
      • Stanford, California, United States, 94305
        • Withdrawn
        • Stanford University Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Denver
        • Principal Investigator:
          • Brett Reece
        • Contact:
          • Brett Reece, MD
      • Colorado Springs, Colorado, United States, 90803
        • Recruiting
        • Memorial Hospital Central
        • Principal Investigator:
          • Mel Sharafuddin, MD
        • Contact:
          • Mel Sharafuddin, MD
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Recruiting
        • Hartford Hospital
        • Principal Investigator:
          • Mohiuddin Cheema, MD
        • Contact:
          • Marianne McCarthy
          • Phone Number: 860-972-1788
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale University
        • Contact:
          • David Kuwayama, MD
        • Principal Investigator:
          • David Kuwayama, MD
    • Florida
      • Gainesville, Florida, United States, 32608
        • Recruiting
        • University of Florida Health
        • Contact:
          • Nancy Hanson
          • Phone Number: 352-273-7598
        • Principal Investigator:
          • Michol Cooper, MD
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Tampa General Hospital
        • Principal Investigator:
          • Halim Yammine, MD
        • Contact:
          • Eric Johnson
          • Phone Number: 813-844-4686
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Principal Investigator:
          • Mark Eskandari, MD
        • Contact:
          • Andrea Silverman
          • Phone Number: 312-926-4000
      • Chicago, Illinois, United States, 60637
        • Withdrawn
        • The University of Chicago
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Southern Illinois University School of Medicine
        • Contact:
          • Rebecca Owens
          • Phone Number: 217-545-7321
        • Principal Investigator:
          • Laura Healy, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Methodist Hospital
        • Principal Investigator:
          • Raghu Motaganahalli, MD
        • Contact:
          • Raghu Motaganahalli, MD
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Contact:
          • William Poulson, MD
        • Principal Investigator:
          • William Poulson, MD
    • Maine
      • Scarborough, Maine, United States, 04101
        • Recruiting
        • MaineHealth
        • Principal Investigator:
          • Kristina Giles, MD
        • Contact:
          • Monica Palmeri
          • Phone Number: 207-662-2090
    • Maryland
      • Baltimore, Maryland, United States, 21230
        • Recruiting
        • Johns Hopkins University
        • Principal Investigator:
          • Caitlin Hicks, MD
        • Contact:
          • Caitlin Hicks, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Contact:
          • BWH Vascular Surgery Research
          • Phone Number: 617-525-8555
        • Principal Investigator:
          • Matthew T Menard, MD
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Matthew Eagleton, MD
        • Contact:
          • Research Office
          • Phone Number: 617-726-8875
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • University of Massachusetts Memorial
        • Principal Investigator:
          • Andres Schanzer, MD
        • Contact:
          • Shauneen Valliere
          • Phone Number: 508-856-1767
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Health
        • Contact:
          • Bo Yang, MD
        • Principal Investigator:
          • Bo Yang, MD
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health System
        • Principal Investigator:
          • Loay Kabbani, MD
        • Contact:
          • Research Office
          • Phone Number: 313-916-8006
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Spectrum Health and Hospitals and Corewell
        • Contact:
          • Eanas Yassa, MD
        • Principal Investigator:
          • Eanas Yassa, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
          • Surgery Clinical Trials Office
          • Phone Number: 612-624-7463
        • Principal Investigator:
          • Nolan Cirillo-Penn, MD
      • Rochester, Minnesota, United States, 55905
        • Withdrawn
        • Mayo Clinic
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • University of Missouri Health Care
        • Principal Investigator:
          • Jonathan Bath, MD
        • Contact:
          • Brianna Ledbetter
          • Phone Number: 573-884-7569
      • St Louis, Missouri, United States, 63110
        • Withdrawn
        • Washington University School of Medicine
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Withdrawn
        • University of Nebraska Medical Center
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Recruiting
        • Cooper University Hospital
        • Contact:
          • Jonelle O'Shea
          • Phone Number: 856-342-2150
        • Principal Investigator:
          • Philip Batista, MD
      • Jersey City, New Jersey, United States, 07302
        • Recruiting
        • Rutgers UH Vascular Center
        • Contact:
          • Karim Salem, MD
        • Principal Investigator:
          • Karim Salem, MD
    • New York
      • Brooklyn, New York, United States, 11219
        • Withdrawn
        • Maimonides Medical Center
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health
        • Contact:
          • Gregory Magee, MD
        • Principal Investigator:
          • Gregory Magee, MD
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
        • Contact:
          • Bridget Coyle
          • Phone Number: 212-241-4461
        • Principal Investigator:
          • Rami Tadros, MD
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester Medical Center
        • Principal Investigator:
          • Doran Mix, MD
        • Contact:
          • Mary Bourret
          • Phone Number: 585-276-1738
      • Roslyn, New York, United States, 11576
        • Recruiting
        • St. Francis Hospital and Heart Center
        • Contact:
          • Timothy Carter, MD
        • Principal Investigator:
          • Timothy Carter, MD
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • Stony Brook University Medical Center
        • Principal Investigator:
          • Apostolos Tassiopoulos, MD
        • Contact:
          • Apostolos Tassiopoulos, MD
      • Syracuse, New York, United States, 13120
        • Recruiting
        • SUNY Upstate Medical University
        • Contact:
          • Maria Walker
          • Phone Number: 315-464-8272
        • Principal Investigator:
          • Palma Shaw, MD
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Withdrawn
        • University of North Carolina Chapel Hill
      • Charlotte, North Carolina, United States, 28201
        • Withdrawn
        • Sanger Heart & Vascular Institute
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Principal Investigator:
          • G. Chad Hughes, MD
        • Contact:
          • G. Chad Hughes, MD
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Harrington Heart and Vascular Institute
        • Contact:
          • Amy Kluge
          • Phone Number: 216-844-2988
        • Principal Investigator:
          • Jae S Cho, MD
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University Medical Center
        • Contact:
          • Xiaoyi Teng, MD
        • Principal Investigator:
          • Xiaoyi Teng, MD
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
          • Amie Lorisch
          • Phone Number: 971-349-6659
        • Principal Investigator:
          • Sherene Shalhub, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania
        • Contact:
          • Nimesh Desai, MD
        • Principal Investigator:
          • Nimesh Desai, MD
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University Hospital
        • Contact:
          • Babak Abai, MD
        • Principal Investigator:
          • Babak Abai, MD
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh Medical Center
        • Principal Investigator:
          • Derek Serna-Gallegos, MD
        • Contact:
          • Erin Cochran
          • Phone Number: 412-647-8467
    • Texas
      • Austin, Texas, United States, 78712
        • Recruiting
        • UT Dell Medical School- Ascension
        • Principal Investigator:
          • George Arnaoutakis, MD
        • Contact:
          • Madeline Gleason
          • Phone Number: 512-324-3434
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern Medical Center
        • Contact:
          • Emma Bryant
          • Phone Number: 214-648-6743
        • Principal Investigator:
          • Michael Shih, MD
      • Dallas, Texas, United States, 75226
        • Recruiting
        • Baylor Scott & White Research Institute
        • Contact:
          • John Eidt, MD
        • Principal Investigator:
          • John Eidt, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital
        • Principal Investigator:
          • Marvin Atkins, MD
        • Contact:
          • Solange Basagoitia
          • Phone Number: 832-301-1168
        • Contact:
          • Saba Khan
          • Phone Number: 832-301-1168
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas Health Houston
        • Principal Investigator:
          • Naveed Saqib, MD
        • Contact:
          • Mariano Montemayor
          • Phone Number: 713-486-5194
      • Plano, Texas, United States, 75093
        • Recruiting
        • Baylor Scott & White The Heart Hospital - Plano
        • Principal Investigator:
          • Dennis Gable, MD
        • Contact:
          • Dennis Gable, MD
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • University of Utah
        • Principal Investigator:
          • Nathan Droz, MD
        • Contact:
          • Julie Hales
          • Phone Number: 801-587-1450
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Sentara Cardiovascular Research Institute
        • Principal Investigator:
          • David Dexter, MD
        • Contact:
          • Kara Wiggins
          • Phone Number: 757-388-7511
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • University of Washington
        • Principal Investigator:
          • Benjamin Starnes, MD
        • Contact:
          • Benjamin Starnes, MD
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Recruiting
        • CAMC Clinical Trials Center
        • Contact:
          • Kristi Sutphin
          • Phone Number: 304-388-9944
        • Principal Investigator:
          • Shadi Abu-halimah, MD
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin
        • Contact:
          • John Rectenwald, MD
        • Principal Investigator:
          • John Rectenwald, MD
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
          • Beth Weseman
          • Phone Number: 414-955-1810
        • Principal Investigator:
          • Joe Hart, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age > 21 years
  2. Patients with a Stanford type B aortic dissection not involving the aorta at or proximal to the innominate artery, without rupture and/or malperfusion syndrome (renal, mesenteric, or extremity) who are within 48 hours to 6 weeks after start of index admission for their type B dissection
  3. Ability to provide written informed consent
  4. Investigator believes anatomy is suitable for TEVAR

Exclusion Criteria:

  1. Ongoing systemic infection
  2. Pregnant or planning to become pregnant in the next 3 months
  3. Life expectancy related to non-aortic conditions < 2 years
  4. Unwilling or unable to comply with all study procedures
  5. Known patient history of genetic aortopathy
  6. Penetrating Aortic Ulcer without concomitant uTBAD
  7. Intramural hematoma without concomitant uTBAD
  8. Iatrogenic (traumatic) aortic dissection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Upfront TEVAR plus Medical Therapy
Participants randomized to upfront TEVAR will receive a commercially available device customized to their individual anatomical requirements. Stent-graft implantation will be performed either in the operating room with appropriate digital imaging equipment to allow fluoroscopic and trans-esophageal echo (TEE) guidance or the catheterization laboratory, angiographic suite (with digital angiographic equipment).
Procedure: TEVAR
Thoracic endovascular aortic repair
Other: Guideline directed medical therapy and surveillance of dissection
Routine clinical care with suggested antihypertensive therapy and cardiovascular risk factor reduction as per appropriate cardiovascular guidelines.
Active Comparator: Medical Therapy with surveillance for deterioration
Participants randomized to upfront Medical Therapy with Surveillance for Deterioration will be treated per routine clinical care with suggested antihypertensive therapy and cardiovascular risk factor reduction as per appropriate cardiovascular guidelines.
Other: Guideline directed medical therapy and surveillance of dissection
Routine clinical care with suggested antihypertensive therapy and cardiovascular risk factor reduction as per appropriate cardiovascular guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause death or major aortic complications (MAC)
Time Frame: Last follow-up timepoint. Differential follow-up with median of about 4 years

The primary endpoint is a composite of all-cause death or major aortic complications (MAC). MACs are defined as:

  • Aortic rupture
  • Malperfusion syndrome
  • New aortic tear requiring intervention,
  • Retrograde aortic dissection,
  • Dependence on outpatient dialysis (chronic)
  • Major amputation (above ankle)
  • Tracheostomy
  • fistula formation (e.g., aorto-esophageal, aorto-tracheal)
  • Spinal Cord Ischemia with paralysis or paresis
  • Stroke

  • AD-related intervention in either group defined as:

    • Open TAA/TAAA Repair
    • Fenestrated and/or Branched Endovascular Repair of TAAA
    • Repeat TEVAR
Last follow-up timepoint. Differential follow-up with median of about 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of cardiovascular (CV) hospitalizations
Time Frame: Last follow-up timepoint. Differential follow-up with median of about 4 years
CV hospitalization will be defined as hospitalization >/= 24 hours for any cardiovascular cause.
Last follow-up timepoint. Differential follow-up with median of about 4 years
Mean number of cardiovascular (CV) hospitalizations
Time Frame: Last follow-up timepoint. Differential follow-up with median of about 4 years
CV hospitalization will be defined as hospitalization >/= 24 hours for any cardiovascular cause.
Last follow-up timepoint. Differential follow-up with median of about 4 years
Incidence of cardiovascular death
Time Frame: Last follow-up timepoint. Differential follow-up with median of about 4 years
Death from any cardiovascular cause.
Last follow-up timepoint. Differential follow-up with median of about 4 years
Incidence of stroke
Time Frame: Last follow-up timepoint. Differential follow-up with median of about 4 years
Defined as a focal neurological deficit that could be attributed to a vascular territory and lasted >24 hours or was associated with a new lesion on computed tomography scan or magnetic resonance imaging.
Last follow-up timepoint. Differential follow-up with median of about 4 years
Incidence of vascular access injury requiring surgical repair
Time Frame: Last follow-up timepoint. Differential follow-up with median of about 4 years
Defined as any open surgical procedure to treat a vascular injury at the site of vascular access for a previous endovascular procedure.
Last follow-up timepoint. Differential follow-up with median of about 4 years
Incidence of aortobronchial / aortoesophageal fistula
Time Frame: Last follow-up timepoint. Differential follow-up with median of about 4 years
Defined as fistulous connection between the aorta and bronchus as confirmed by chest imaging or direct visualization (surgical or bronchoscopic). Aortoesophageal fistula is defined as a fistulous connection between the aorta and the esophagus as confirmed by chest imaging or direct visualization (surgical or endoscopically).
Last follow-up timepoint. Differential follow-up with median of about 4 years
Incidence of retrograde type A dissection
Time Frame: Last follow-up timepoint. Differential follow-up with median of about 4 years
Defined as any new ascending arch, or descending dissection contiguous with and proximal to the original presenting anatomy as confirmed by imaging.
Last follow-up timepoint. Differential follow-up with median of about 4 years
Number of days alive and out of the hospital
Time Frame: Last follow-up timepoint. Differential follow-up with median of about 4 years
Defined as the number of days alive minus the number of days in the hospital over 4 years (primary analysis).
Last follow-up timepoint. Differential follow-up with median of about 4 years
Incidence of secondary percutaneous interventions after TEVAR
Time Frame: Last follow-up timepoint. Differential follow-up with median of about 4 years
Any secondary percutaneous intervention after TEVAR
Last follow-up timepoint. Differential follow-up with median of about 4 years
Quality of Life, as measured by the Abdominal Aortic Aneurysm Quality of Life questionnaire (AAAQol)
Time Frame: Last follow-up timepoint. Differential follow-up with median of about 4 years
An adapted version of the AAAQol survey and the PROMIS-16 will be used to assess general and aortic specific quality of life. The AAAQol questionnaire was specifically developed and validated on patients with abdominal aortic aneurysms and measures both the physical and emotional impact of either 1) having an abdominal aortic aneurysm or 2) having surgical or endovascular therapy for an abdominal aortic aneurysm. This metric has been shown to be valid and responsive in abdominal aortic aneurysm. While it has not been tested in aortic dissection, its questions assess the same domains shown to be significantly impacted in patients with aortic dissection.
Last follow-up timepoint. Differential follow-up with median of about 4 years
Incidence of all-cause death
Time Frame: Last follow-up timepoint. Differential follow-up with median of about 4 years
Death from any case
Last follow-up timepoint. Differential follow-up with median of about 4 years
Cumulative incidence of major aortic complications (MAC)
Time Frame: Last follow-up timepoint. Differential follow-up with median of about 4 years
Composite endpoint. MACs are defined as: • Aortic rupture • Malperfusion syndrome • New aortic tear requiring intervention, • Retrograde aortic dissection, • Dependence on outpatient dialysis (chronic) • Major amputation (above ankle) • Tracheostomy • fistula formation (e.g., aorto-esophageal, aorto-tracheal) • Spinal Cord Ischemia with paralysis or paresis • Stroke • AD-related intervention in either group defined as: - Open TAA/TAAA Repair - Fenestrated and/or Branched Endovascular Repair of TAAA - Repeat TEVAR
Last follow-up timepoint. Differential follow-up with median of about 4 years
Incidence of paraplegia or paraparesis
Time Frame: Last follow-up timepoint. Differential follow-up with median of about 4 years
Defined as including: 1) flaccid paraplegia (no lower extremity movement), or lower extremity movement without gravity, or lower extremity movement with gravity, or standing with assistance or walking with assistance.
Last follow-up timepoint. Differential follow-up with median of about 4 years
Incidence of aortic-related death
Time Frame: Last follow-up timepoint. Differential follow-up with median of about 4 years
Aortic-related death will be defined as death within 30 days of 1) diagnosis of aortic dissection 2) any aortic intervention or 3) ruptured aortic aneurysm.
Last follow-up timepoint. Differential follow-up with median of about 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

The University of Texas Health Science Center, Houston
National Heart, Lung, and Blood Institute (NHLBI)
Oregon Health and Science University
State University of New York - Downstate Medical Center

Investigators

  • Principal Investigator: Manesh R Patel, M.D., Duke University
  • Principal Investigator: Firas F Mussa, M.D., The University of Texas at Houston
  • Principal Investigator: Panos Kougias, M.D., The State University of New York at Downstate
  • Principal Investigator: Sreekanth Vemulapalli, M.D., Duke University
  • Principal Investigator: Sean O'Brien, Ph.D., Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2024

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

June 30, 2030

Study Registration Dates

First Submitted

October 11, 2023

First Submitted That Met QC Criteria

October 11, 2023

First Posted (Actual)

October 17, 2023

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00113329
  • 4UH3HL165017-02 (U.S. NIH Grant/Contract)
  • 5U24HL165029-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Statistical and data analytic center (SDCC) will submit to the NHLBI data repository de-identified Limited Access Datasets (LADs) and associated documentation, for use by other investigators. The LADs and documentation will be submitted within 2 years after publication of the primary results manuscript. Documentation will include copies of the case report forms; a list of derived variables and the formulas used to create them; and a codebook providing for each variable the variable name, coding conventions, and distribution of values. It will also include a list of data modifications made when creating the LAD, and a copy of the informed consent template, so that future use of the data will be consistent with the consent provided by the study subjects.The goal is to make data available to other investigators while protecting the rights and privacy of the subjects who participated in the studies. The SDCC will anonymize the datasets.

IPD Sharing Time Frame

2 years

IPD Sharing Access Criteria

The methods for restricting access will also need to be determined, either with password access and/or with executed Data Agreements. Related to the restricted use of data is the need to specify appropriately in informed consent forms that the study participant's de-identified data may be made available to other researchers.

IPD Sharing Supporting Information Type

  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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