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Trial record 1 of 2 for:    suburban AND cardiovascular disease screening protocol
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Cardiovascular Disease Screening

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier:
NCT00483951
First received: June 7, 2007
Last updated: November 25, 2014
Last verified: November 2014

June 7, 2007
November 25, 2014
June 2007
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Complete list of historical versions of study NCT00483951 on ClinicalTrials.gov Archive Site
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Cardiovascular Disease Screening
Suburban/NHLBI Cardiovascular Disease Screening Protocol

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.)

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.

Observational
Time Perspective: Prospective
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  • Congenital Heart Disease
  • Atherosclerosis
  • Myocardial Ischemia
  • Myocardial Infarction
  • Acquired Heart Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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  • 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.
Both
18 Years and older
No
Contact: Marsha Block, R.N. (301) 496-0211 blockma@mail.nih.gov
Contact: Andrew E Arai, M.D. (301) 496-3658 araia@nih.gov
United States
 
NCT00483951
070157, 07-H-0157
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National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Andrew E Arai, M.D. National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health Clinical Center (CC)
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP