NCT00483951

Brief Summary

This study will evaluate volunteers 18 years of age and older to see if they qualify for one of NHLBI s research studies. Tests include the following:

  • General medical evaluation, which may include blood tests, chest x-ray, electrocardiogram (ECG) and echocardiogram (heart ultrasound).
  • Other tests as appropriate, such as magnetic resonance imaging (MRI), cardiac computed tomography (CT scan of the heart), nuclear stress test and echocardiography stress test.
  • X-ray contrast studies of the heart and blood vessels. (These may be excluded in patients with kidney risk factors.)

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1,325

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

June 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2007

Completed
8 months until next milestone

Study Start

First participant enrolled

January 28, 2008

Completed
12.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2020

Completed
Last Updated

July 29, 2021

Status Verified

November 1, 2020

Enrollment Period

12.8 years

First QC Date

June 7, 2007

Last Update Submit

July 28, 2021

Conditions

Congenital Heart DiseaseAtherosclerosisMyocardial IschemiaMyocardial InfarctionAcquired Heart Disease

Keywords

Transthoracic echocardiographyIschemiaCardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Complete characterization of patients for screening purpose onto a research protocol.

    Complete characterization of patients for the purpose of deciding whether they are eligible for research protocols run by the Cardiovascular Branch.

    Ongoing

Study Arms (1)

Patients with known or suspected cardiovascular disease

Patients referred to protocol with known or suspected cardiovascular disease for further evaluation.

Device: Toshiba Aquilion ONE CTDevice: SWiemens MRI scanner

Interventions

Toshiba Aquilion ONE CTDEVICE

The Toshiba Aquilion ONE CT system has the ability to acquire whole organ volume images in a single rotation by utilizing an x-ray detector that is configured as 320 detector rows with a 0.5 mm width, providing a z-axis coverage of 16 cm of anatomy.

Patients with known or suspected cardiovascular disease
SWiemens MRI scannerDEVICE

Investigational or research MRI coils may be used in the protocol. The coils are noninvasive devices external to the body. The coils act as antennae to receive small radiofrequency signals out of the body. Coils of the type we use are used daily in clinical MRI practice.

Patients with known or suspected cardiovascular disease

Eligibility Criteria

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

Patients \> 18 years of age referred for possible cardiovascular disease will be enrolled in the protocol for a period of one year. At one year, patients will either be: 1) transferred to one of our specific research MRI or CT protocols, 2) removed from the screening protocol and made inactive, or 3) re-enrolled on the screening protocol with the patient's consent.

You may qualify if:

  • Age greater than or equal to 18
  • Capable of giving informed consent.

You may not qualify if:

  • Pregnant women (uncertain patients will have urine or blood testing).
  • Decompensated heart failure (unable to lie flat in bed).
  • Allergy to iodinated contrast agent excludes contrast enhanced CT research studies.
  • Multiple myeloma.
  • Patients with severe kidney disease (eGFR less than 30 mL/min/1.73 m(2).
  • Asthma or severe chronic lung disease/emphysema with regular use of inhaler.
  • Decompensated heart failure.
  • Cardiac pacemaker or implantable defibrillator.
  • Cerebral aneurysm clip.
  • Neural stimulator (e.g. TENS-Unit).
  • Any type of ear implant.
  • Metal in eye (e.g. from machining).
  • Any implanted device (e.g. insulin pump, drug infusion device).
  • Lactating women unless they are willing to discard breast milk for 24 hours.
  • Severe kidney disease (less than 30 mL/min/1.73 m(2).
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Escolar E, Weigold G, Fuisz A, Weissman NJ. New imaging techniques for diagnosing coronary artery disease. CMAJ. 2006 Feb 14;174(4):487-95. doi: 10.1503/cmaj.050925.

    PMID: 16477061BACKGROUND

  • White CS, Kuo D, Kelemen M, Jain V, Musk A, Zaidi E, Read K, Sliker C, Prasad R. Chest pain evaluation in the emergency department: can MDCT provide a comprehensive evaluation? AJR Am J Roentgenol. 2005 Aug;185(2):533-40. doi: 10.2214/ajr.185.2.01850533.

    PMID: 16037533BACKGROUND

  • Hendel RC, Patel MR, Kramer CM, Poon M, Hendel RC, Carr JC, Gerstad NA, Gillam LD, Hodgson JM, Kim RJ, Kramer CM, Lesser JR, Martin ET, Messer JV, Redberg RF, Rubin GD, Rumsfeld JS, Taylor AJ, Weigold WG, Woodard PK, Brindis RG, Hendel RC, Douglas PS, Peterson ED, Wolk MJ, Allen JM, Patel MR; American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group; American College of Radiology; Society of Cardiovascular Computed Tomography; Society for Cardiovascular Magnetic Resonance; American Society of Nuclear Cardiology; North American Society for Cardiac Imaging; Society for Cardiovascular Angiography and Interventions; Society of Interventional Radiology. ACCF/ACR/SCCT/SCMR/ASNC/NASCI/SCAI/SIR 2006 appropriateness criteria for cardiac computed tomography and cardiac magnetic resonance imaging: a report of the American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group, American College of Radiology, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, American Society of Nuclear Cardiology, North American Society for Cardiac Imaging, Society for Cardiovascular Angiography and Interventions, and Society of Interventional Radiology. J Am Coll Cardiol. 2006 Oct 3;48(7):1475-97. doi: 10.1016/j.jacc.2006.07.003. No abstract available.

    PMID: 17010819BACKGROUND

Related Links

MeSH Terms

Conditions

Heart Defects, CongenitalAtherosclerosisMyocardial IschemiaMyocardial InfarctionIschemiaCardiovascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Andrew E Arai, M.D.

    National Heart, Lung, and Blood Institute (NHLBI)

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 7, 2007

First Posted

June 8, 2007

Study Start

January 28, 2008

Primary Completion

November 3, 2020

Study Completion

November 3, 2020

Last Updated

July 29, 2021

Record last verified: 2020-11

Locations

US(2)