NCT00181233

Brief Summary

Sudden cardiac death is a tragic event that strikes all age groups and is unfortunately increasing in prevalence. Because it is difficult to predict those at highest risk, this study is designed to test the hypothesis that new imaging techniques (magnetic resonance imaging \[MRI\] and computed tomography \[CT\]) are useful for identifying factors which put people at high risk for sudden death.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
39mo left

Started Oct 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Oct 2003Jul 2029

Study Start

First participant enrolled

October 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
22.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

24.4 years

First QC Date

September 13, 2005

Last Update Submit

January 12, 2026

Conditions

Sudden Cardiac Death

Outcome Measures

Primary Outcomes (4)

  • sudden cardiac death

    6 month intervals

  • cardiovascular death

    6 month intervals

  • appropriate ICD discharge

    6 month intervals

  • composite sudden cardiac death and appropriate ICD discharge

    6 month intervals

Secondary Outcomes (1)

  • heart failure admission

    6 month intervals

Other Outcomes (4)

  • cardiac transplantation

    6 month intervals

  • myocardial revascularization

    6 month intervals

  • left ventricular assist device placement

    6 month intervals

  • +1 more other outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with contractile dysfunction (EF\< or = 35%) on an ischemic or non-ischemic basis undergoing clinically-indicated ICD implantation for primary prevention of sudden cardiac death (SCD)

You may qualify if:

  • Left ventricular ejection fraction \<or = 35%
  • Planned implantable cardioverter-defibrillator (ICD) implantation for clinical indications (primary prevention)

You may not qualify if:

  • History of sudden death (secondary prevention)
  • Contraindication to undergoing MRI (metallic implant, pacemaker, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21287, United States

RECRUITING

Related Publications (3)

  • Samuel TJ, Lai S, Schar M, Wu KC, Steinberg AM, Wei AC, Anderson ME, Tomaselli GF, Gerstenblith G, Bottomley PA, Weiss RG. Myocardial ATP depletion detected noninvasively predicts sudden cardiac death risk in patients with heart failure. JCI Insight. 2022 Jun 22;7(12):e157557. doi: 10.1172/jci.insight.157557.

    PMID: 35579938DERIVED

  • Wu KC, Gerstenblith G, Guallar E, Marine JE, Dalal D, Cheng A, Marban E, Lima JA, Tomaselli GF, Weiss RG. Combined cardiac magnetic resonance imaging and C-reactive protein levels identify a cohort at low risk for defibrillator firings and death. Circ Cardiovasc Imaging. 2012 Mar;5(2):178-86. doi: 10.1161/CIRCIMAGING.111.968024. Epub 2012 Jan 20.

    PMID: 22267750DERIVED

  • Wu KC, Weiss RG, Thiemann DR, Kitagawa K, Schmidt A, Dalal D, Lai S, Bluemke DA, Gerstenblith G, Marban E, Tomaselli GF, Lima JA. Late gadolinium enhancement by cardiovascular magnetic resonance heralds an adverse prognosis in nonischemic cardiomyopathy. J Am Coll Cardiol. 2008 Jun 24;51(25):2414-21. doi: 10.1016/j.jacc.2008.03.018.

    PMID: 18565399DERIVED

MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Katherine C Wu, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Butcher, RN

CONTACT

443-287-3472bbutche1@jhmi.edu

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

October 1, 2003

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

July 1, 2029

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)