NCT01745237

Brief Summary

The primary objective of this study was to determine the ability of cardiac magnetic resonance (CMR) to identify cardiac involvement in patients with sarcoidosis. Patients were to undergo CMR in addition to routine clinical evaluation.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
27,000

participants targeted

Target at P75+ for all trials

Timeline
73mo left

Started Sep 2002

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 Progress80%
Sep 2002Jun 2032

Study Start

First participant enrolled

September 1, 2002

Completed
10.3 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 10, 2012

Completed
19.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2032

Last Updated

April 13, 2025

Status Verified

April 1, 2025

Enrollment Period

29.8 years

First QC Date

December 6, 2012

Last Update Submit

April 10, 2025

Conditions

Sarcoidosis

Keywords

SarcoidosisCardiac Magnetic Resonance

Outcome Measures

Primary Outcomes (3)

  • cardiac mortality

    > 1year

  • arrhythmic death

    > 1year

  • Pulmonary mortality

    only in subset of patients with pulmonary sarcoidosis

    > 1year

Secondary Outcomes (5)

  • all-cause mortality

    > 1year

  • arrhythmic events

    > 1year

  • Pulmonary Transplant

    > 1 year

  • Cardiac Transplant

    > 1 year

  • PPM placement/high grade AV block

    > 1 year

Eligibility Criteria

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

Patients with biopsy proven sarcoidosis or suspected cardiac sarcoidosis

You may qualify if:

  • Biopsy proven sarcoidosis
  • Suspected cardiac sarcoidosis

You may not qualify if:

  • Contraindication to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27707, United States

RECRUITING

Related Publications (1)

  • Patel MR, Cawley PJ, Heitner JF, Klem I, Parker MA, Jaroudi WA, Meine TJ, White JB, Elliott MD, Kim HW, Judd RM, Kim RJ. Detection of myocardial damage in patients with sarcoidosis. Circulation. 2009 Nov 17;120(20):1969-77. doi: 10.1161/CIRCULATIONAHA.109.851352. Epub 2009 Nov 2.

    PMID: 19884472RESULT

MeSH Terms

Conditions

Sarcoidosis

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Study Officials

  • Raymond J Kim, MD

    Duke Cardiovascular Magnetic Resonance Center, Duke University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Han W Kim, MD

CONTACT

919-668-3539kim00050@duke.edu

Raymond J. Kim, MD

CONTACT

919-668-3539kim00049@duke.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2012

First Posted

December 10, 2012

Study Start

September 1, 2002

Primary Completion (Estimated)

June 1, 2032

Study Completion (Estimated)

June 1, 2032

Last Updated

April 13, 2025

Record last verified: 2025-04

Locations

US(1)