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Cardiovascular Disease Screening

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ClinicalTrials.gov Identifier: NCT00483951
Recruitment Status : Suspended
First Posted : June 8, 2007
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

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.)

Condition or disease
Congenital Heart Disease Atherosclerosis Myocardial Ischemia Myocardial Infarction Acquired Heart Disease

Detailed Description:

This is a screening protocol. This protocol allows two functions: 1) the protocol allows physicians in the Suburban/NHLBI Cardiovascular Imaging program to evaluate patients referred to the program with clinically indicated studies and research studies. 2) It is also designed to determine if patients may be suitable candidates for one of our NHLBI research protocols.

Patients greater than or equal to 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.


Study Type : Observational
Actual Enrollment : 1325 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Suburban/NHLBI Cardiovascular Disease Screening Protocol
Study Start Date : June 6, 2007



Primary Outcome Measures :
  1. to evaluate patients with known or suspected cardiovascular disease with a combination of electrocardiography, chest Xray, nuclear stress testing, laboratory testing, echocardiography, stress echocardiography, cardiac CT, and cardiac MRI.
    The outcome of this screening protocol will be more complete characterization of patients for the purpose of deciding whether they are eligible for research protocols run by the Laboratory of Cardiac Energetics, the Cardiothoracic Surgery Branch, or the CardiovascularBranch.


Secondary Outcome Measures :
  1. The outcome of this screening protocol will be more complete characterization of patients for the purpose of deciding whether they are eligible for research protocols run by the LCE/CPB.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 125 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria
  • ELIGIBILITY CRITERIA:

No one will be excluded from this study based on race, gender, or ethnicity.

A. General Inclusion Criteria:

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

B. General Exclusion Criteria (for all arms):

  • Pregnant women (uncertain patients will have urine or blood testing).
  • Decompensated heart failure (unable to lie flat in bed).

Test Specific Exclusion Criteria:

A. CT Exclusion Criteria (excludes contrast enhanced CT scan only):

  • 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).

B. Beta Antagonist Exclusions (excluded the use of beta blocker only):

  • Asthma or severe chronic lung disease/emphysema with regular use of inhaler.
  • Decompensated heart failure.

C. MRI Exclusion Criteria (excludes MRI scan only):

  • 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).

D. Exclusions from MRI contrast agents:

  • 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).

E. Vasodilator Exclusions (excludes some vasodilator stress testing):

  • Asthma or chronic obstructive pulmonary disease (emphysema) actively treated with bronchodilators or leukotriene receptor antagonists (albuterol, seravent, atrovent, montelukast singulair, zafirlukast Accolate. These conditions only exclude adenosine and dipyridamole.
  • Second degree (Type II) and third degree atrioventricular heart block.

F. Exclusions from Dobutamine stress MRI only:

  • Severe problems with heart rhythms.
  • Severe high blood pressure.

G. Exclusion criteria for atropine (given during dobutamine stress echocardiography when target heart rate not achievable with dobutamine alone).

  • Narrow angle glaucoma.
  • Known or suspected severe bladder outlet obstruction due to prostatic hypertrophy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00483951


Locations
United States, Maryland
Suburban Hospital
Bethesda, Maryland, United States, 20814
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Andrew E Arai, M.D. National Heart, Lung, and Blood Institute (NHLBI)

Additional Information:
Publications:
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. Review.

Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00483951     History of Changes
Other Study ID Numbers: 070157
07-H-0157
First Posted: June 8, 2007    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: August 28, 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Transthoracic echocardiography
Ischemia
Cardiovascular Disease
Heart Disease
Congenital Heart Disease
Heart Valve Disease
Atherosclerosis

Additional relevant MeSH terms:
Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Ischemia
Atherosclerosis
Heart Defects, Congenital
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Necrosis
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Coronary Disease