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.
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:
- Evaluate the diagnostic and prognostic performance of MDCT in patients with equivocal/ intermediate post test probability of CAD and
- Evaluate the accuracy of MDCT in prediction of 30 day major adverse events.
- Conditions
- Coronary Angiography, Coronary Disease
- 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.
- First posted25 Apr 2007 (estimated)
- Study startMar 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary AngiographyStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Investigators
- Gilbert Raff, M.D., Study director, Corewell Health EastJames Goldstein, M.D., Study chair, Corewell Health EastMichael Gallagher, M.D., Principal investigator, Corewell Health EastGilbert Raff, M.D., Principal investigator, Corewell Health East
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Detector Computer Tomography(MDCT)in Patients With Equivocal/Intermediate Post Test Probability of Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00465335
- Acronym / sponsor ID
- IMPACCT / 2005-135 IMPACCT
- Conditions
- Coronary Angiography, Coronary Disease
- Keywords
- computed tomography, stress test, equivocal, catheterization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- Mar 2006
- Study completion
- Feb 2007 (actual)
- First posted
- 25 Apr 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.
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.)
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:
- Evaluate the diagnostic and prognostic performance of MDCT in patients with equivocal/ intermediate post test probability of CAD and
- Evaluate the accuracy of MDCT in prediction of 30 day major adverse events.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chest pain over the age of 18 years old with symptoms of Coronary Artery Disease
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2012.
Related trials for Coronary Angiography
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Randomized Prospective Trial on the Cost-Effectiveness of Photon-Counting CT Versus Energy-Integrating Detector CT in Suspected Chronic Coronary Syndrome
Computed Tomography Angiography, Coronary Artery Disease
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Not yet recruiting
Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
Coronary In-stent Restenosis, Coronary Artery Disease
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
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.
Gilbert Raff, M.D. study director
Corewell Health East
James Goldstein, M.D. study chair
Corewell Health East
Michael Gallagher, M.D. principal investigator
Corewell Health East
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.