Congenital Heart DiseaseNCT00483951
Cardiovascular Disease Screening
An observational study of Congenital Heart Disease and Atherosclerosis, run by National Heart, Lung, and Blood Institute (NHLBI) at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Heart Disease, Atherosclerosis, Myocardial Ischemia
- What is being tested?
- Toshiba Aquilion ONE CT and SWiemens MRI scanner
- Type of treatment
- Medical device
- How many people
- 1,325 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Jan 2008to 3 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
- ELIGIBILITY CRITERIA:
No one will be excluded from this study based on race, gender, or ethnicity.
- General Inclusion Criteria:
- Age greater than or equal to 18
- Capable of giving informed consent.
- General Exclusion Criteria:
- Pregnant women (uncertain patients will have urine or blood testing).
- Decompensated heart failure (unable to lie flat in bed).
Test Specific Exclusion Criteria:
- 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).
- 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.
- 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).
- 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).
- 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.
- Exclusions from Dobutamine stress MRI only:
- Severe problems with heart rhythms.
- Severe high blood pressure.
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Suburban Hospital
Bethesda, Maryland, 20814
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: 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.)
Read the 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.
- Conditions
- Congenital Heart Disease, Atherosclerosis, Myocardial Ischemia, Myocardial Infarction, Acquired Heart Disease
- Being tested
- Toshiba Aquilion ONE CT, SWiemens MRI scanner
- Keywords
- Transthoracic echocardiography, Ischemia, Cardiovascular Disease
- Medical subject headings
- Heart Defects, Congenital, Atherosclerosis, Myocardial Ischemia, Myocardial Infarction, Ischemia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with known or suspected cardiovascular disease | Patients referred to protocol with known or suspected cardiovascular disease for further evaluation. Receives: Device: Toshiba Aquilion ONE CT; Device: SWiemens MRI scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2007 (estimated)
- Study start28 Jan 2008
- Primary completion3 Nov 2020
- Study completion3 Nov 2020
Why it stopped: Per IRB recommendation, a separate protocol will be prepared for retrospective data analysis. The current protocol does not have specific hypotheses.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,325 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Andrew E Arai, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00483951
- Sponsor's protocol ID
- 070157
- Other IDs
- 07-H-0157
- Status last verified
- Nov 2020
- First submitted
- 7 Jun 2007
- Last updated
- 29 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 16477061White 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.
PubMed 16037533Hendel 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.
PubMed 17010819
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suburban/NHLBI Cardiovascular Disease Screening Protocol
- ClinicalTrials.gov ID
- NCT00483951
- Acronym / sponsor ID
- 070157
- Conditions
- Congenital Heart Disease, Atherosclerosis, Myocardial Ischemia, Myocardial Infarction, Acquired Heart Disease
- Keywords
- Transthoracic echocardiography, Ischemia, Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Per IRB recommendation, a separate protocol will be prepared for retrospective data analysis. The current protocol does not have specific hypotheses.
- Enrolment
- 1,325 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 28 Jan 2008 (actual)
- Primary completion
- 3 Nov 2020 (actual)
- Study completion
- 3 Nov 2020 (actual)
- First posted
- 8 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.)
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with known or suspected cardiovascular disease | – | Device: Toshiba Aquilion ONE CT, Device: SWiemens MRI scannerPatients referred to protocol with known or suspected cardiovascular disease for further evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toshiba Aquilion ONE CTThe 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. | Device | Patients with known or suspected cardiovascular disease |
| SWiemens MRI scannerInvestigational 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. | Device | Patients with known or suspected cardiovascular disease |
Primary outcome
Complete characterization of patients for screening purpose onto a research protocol.
Time frame: Ongoing
Complete characterization of patients for the purpose of deciding whether they are eligible for research protocols run by the Cardiovascular Branch.
Results and safety
The study was stopped early (reason given: Per IRB recommendation, a separate protocol will be prepared for retrospective data analysis. The current protocol does not have specific hypotheses.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Background: PubMed 16477061Escolar 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.
- Background: PubMed 16037533White 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.
- Background: PubMed 17010819Hendel 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew E Arai, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Atherosclerosis, run by National Heart, Lung, and Blood Institute (NHLBI) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Per IRB recommendation, a separate protocol will be prepared for retrospective data analysis. The current protocol does not have specific hypotheses.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete characterization of patients for screening purpose onto a research protocol. (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00483951, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.