Delayed-Enhancement Cardiovascular Magnetic Resonance in... | NCT01745237

Studies
Delayed-Enhancement Cardiovascular Magnetic Resonance in Patients With Sarcoidosis

NCT01745237

Sponsor

Duke University

Status

Recruiting

Last Update Posted

Apr 13, 2025Actual

Enrollment

27,000Estimated

Phase

Not provided

Conditions

Sarcoidosis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
DCMRC-8224a	Other Identifier	DUMC

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2002Actual

Primary Completion Date

Jun 2032Estimated

Completion Date

Jun 2032Estimated

First Submitted Date

Dec 6, 2012

First Submission Date that Met QC Criteria

Dec 6, 2012

First Posted Date

Dec 10, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2025

Last Update Posted Date

Apr 13, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

In patients with sarcoidosis, cardiac death is a leading cause of mortality which may represent unrecognized cardiac involvement. Cardiovascular magnetic resonance (CMR) can detect cardiac involvement including minute amounts of myocardial damage. Therefore, the objective of this study was to determine the usefulness of CMR and compare it with standard clinical evaluation for cardiac involvement. Patients with documented extracardiac sarcoidosis or clinically suspected cardiac sarcoidosis will be enrolled.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

27,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cardiac mortality		> 1year
arrhythmic death		> 1year
Pulmonary mortality	only in subset of patients with pulmonary sarcoidosis	> 1year

Secondary Outcomes

Measure	Description	Time Frame
all-cause mortality		> 1year
arrhythmic events		> 1year
Pulmonary Transplant

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Biopsy proven sarcoidosis
Suspected cardiac sarcoidosis

Exclusion Criteria:

Contraindication to MRI

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with biopsy proven sarcoidosis or suspected cardiac sarcoidosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Han W Kim, MD	Contact	919-668-3539		kim00050@duke.edu
Raymond J. Kim, MD	Contact	919-668-3539		kim00049@duke.edu

Overall Officials

Name	Affiliation	Role
Raymond J Kim, MD	Duke Cardiovascular Magnetic Resonance Center, Duke University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Duke University Medical Center	Recruiting	Durham	North Carolina	27707	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19884472	Result	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.

ID	Term
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D006968	Hypersensitivity, Delayed