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Coronary AngiographyIMPACCTNCT00465335

Usefulness of Coronary CT Angiography in Patients With Inconclusive Stress Test Results

An observational study of Coronary Angiography and Coronary Disease, run by Corewell Health East.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the usefulness of performing a "cat scan" of the heart arteries in patients (without a known history of heart disease) seen by their physician for chest pain. We plan to evaluate this test in patients who have already undergone stress testing. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Coronary Angiography, Coronary Disease
How many people
200 participants
Where
No sites listed yet
Study dates
Mar 2006to Feb 2007
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with chest pain over the age of 18 years old with symptoms of Coronary Artery Disease

Who may be able to join

  • Age >18 years old.
  • Patient with Chest Pain or other symptoms suggestive of Coronary Artery Diseae
  • Stress ECG, Stress Echo, or Stress Nuclear in past 6 months.
  • Equivocal test results or discordant clinical/stress information
  • Able to provide consent

Who cannot join

  • Known coronary artery disease
  • Renal Insufficiency(creatinine > 1.5 mg/dl)or renal failure requiring dialysis
  • Pregnancy or unknown pregnancy status
  • Clinical Instability as deemed by attending physician;including cardiogenic shock, sustained ventricular or atrial arrhythmia requiring intravenous medications, hypotension
  • Patient's with known allergy to iodine or shellfish
  • Inability to tolerate Beta Blockers
  • Use of Viagra or Cialis in past 24 hours
  • Body Mass (BMI)>38

About this study

Official title: Multi-Detector Computer Tomography(MDCT)in Patients With Equivocal/Intermediate Post Test Probability of Coronary Artery Disease

The purpose of this study is to evaluate the usefulness of performing a "cat scan" of the heart arteries in patients (without a known history of heart disease) seen by their physician for chest pain. We plan to evaluate this test in patients who have already undergone stress testing. On occasion, stress test results are equivocal or suspected to be inaccurate. In these cases, depending on the overall clinical suspicion of coronary artery disease, physicians may recommend cardiac catheterization to determine whether or not patients have blockages in their heart's arteries. We plan to evaluate whether a Cat Scan of the heart arteries will provide your physician with important information to assist in this decision. If the results of this test are normal, the patient may not require a heart catheterization; alternatively, if the test is abnormal, a physician may proceed with catheterization after review of the data. There will 200 patients enrolled into the study. All patients will be followed by their usual cardiologist, and all decisions will be made by their cardiologist.

Computed tomography (CT; "cat scan") is an x-ray test routinely used for diagnostic purposes. Cardiac computed tomography using the newer generation multislice CT (MSCT) scanners is an improved way of using CT scanning techniques to look at the heart and blood vessels of the body. The images of the coronary arteries obtained by MSCT scanners (during a 5-10 minute procedure) are highly accurate, when compared to the conventional invasive cardiac catheterization procedure. This procedure will provide a calculation of a coronary artery calcium score as well as an accurate depiction of the coronary anatomy. The accuracy of this test is similar to that achieved with traditional stress test imaging, but has some inherent advantages over this traditional stress testing. Therefore, we believe that in patients with intermediate, inconclusive, or suspected inaccurate stress tests, MSCT of the coronary arteries may provide helpful information to your physician to help guide their decision regarding the need (or lack of) for possible invasive cardiac catheterization. This procedure is considered an ideal "screening test" to exclude the presence of coronary artery disease in patients with suspected coronary artery disease.

On the day of your procedure, the patient will be given intravenous ("IV dye") contrast during their Cat Scan. We will also draw a blood sample to assess your kidney function and/or pregnancy status (if necessary). The contrast is what creates the pictures of one's arteries. The intravenous contrast used is the same dye as that used for routine cat scans of other parts of the body, as well as for cardiac catheterization. Prior to the Scan patients may be prescribed a medicine called a beta blocker The beta blocker typically used is called Atenolol. This medication slows your heart rate and is one that is commonly used to treat high blood pressure. Dosing will be based upon your current medications and vital signs. If a patient's heart rate is greater than 60 beats per minute an intravenous beta-blocker may be given to optimize their heart images. Patient's will have to hold your breath twice, for up to 30 seconds each time. The imaging part of the test takes about 10 minutes. Patient's will be observed after the test for about 20 minutes, followed by discharge home. Physicians will called with the patient's results of the study, and they will contact their patient's regarding the results, as well as the "next step." If a patient is a diabetic (taking metformin/glucophage), we will request a follow up (the next day) kidney test. Patient's will also will be called at 3 months to asked a few brief questions regarding your health (any recent hospitalizations, any new medical illnesses, any follow up heart testing, etc.)

Read the detailed description

The purpose of this observational study is to prospectively evaluate the impact of multi detector CT angiography (MDCT) in patients with equivocal/intermediate post exercise stress test probability of coronary artery disease.

The primary objective are to:

  1. Evaluate the diagnostic and prognostic performance of MDCT in patients with equivocal/ intermediate post test probability of CAD and
  2. Evaluate the accuracy of MDCT in prediction of 30 day major adverse events.
Keywords
computed tomography, stress test, equivocal, catheterization
Medical subject headings
Coronary Disease

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2007 (estimated)
  2. Study startMar 2006
  3. Study completionFeb 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00465335
Sponsor's protocol ID
2005-135 IMPACCT
Acronym
IMPACCT
Status last verified
Sep 2012
First submitted
24 Apr 2007
Last updated
21 Sep 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Angiography and Coronary Disease, run by Corewell Health East.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. 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: finished, as of the sponsor's last update on 21 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

Where can I read the original study information?
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 21 Sep 2012.

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