Known CAD, or Intermediate-high Pretest Likelihood for CADSPARCNCT00321399
Study of Perfusion and Anatomy's Role in Coronary Artery (CAD)
An observational study of Known CAD, or Intermediate-high Pretest Likelihood for CAD, run by Brigham and Women's Hospital at 41 sites in 2 countries.
Trial summary
Three main clinical outcomes will be assessed: 1. Post-test resource utilization as assessed by referral rate to catheterization within 90-days of the index study; 2. Incremental prognostic value and risk stratification for predicting cardiac death and myocardial infarction; 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Known CAD, or Intermediate-high Pretest Likelihood for CAD
- How many people
- 3,019 participants
- Where
- 41 sitesin 2 countries
- Study dates
- Jun 2006to Jul 2014
- 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 with known coronary artery disease and patients with suspected CAD and an intermediate-High Likelihood of disease
Who may be able to join
- Referred for a clinical stress SPECT, stress PET, CTA or PET-CT study
- Intermediate to high pretest likelihood for CAD (>.25;as defined by ACC/AHA Stable Angina Guidelines) without prior MI/PCI/CABG. These are considered diagnostic patients.
- or
- Documented known CAD as defined by prior MI/PCI/CABG
- Provide signed informed consent to participate in the study
Who cannot join
- Low pretest likelihood for CAD (<=.25; as defined by ACC/AHA Stable Angina Guidelines).
- Major concomitant noncardiac disease or social condition/situation that in the opinion of the investigator will preclude the patient from participation in the study follow-up.
- Concurrent or prior(within last 30 days) participation in other research studies using investigational drugs or devices.
- Presence of a permanent automated internal cardiac defibrillator (AICD)
- Known non-ischemic cardiomyopathy
- Chest pain at rest within 48 hours prior to the index noninvasive imaging test
Trial locations and contacts
41 sites in 2 countries.
41 sites in 2 countries
United States40 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory Crawford Long Hospital
Atlanta, Georgia, 30308
Fugua Heart Center - Piedmont Hospital
Atlanta, Georgia, 30309
Sinai Hosptial of Baltimore
Baltimore, Maryland, 21215
Cardiovascular Associates
Birmingham, Alabama, 35213
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hosptial
Boston, Massachusetts, 02115
Lahey Clinic
Burlington, Massachusetts, 01805
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic Foundation
Cleveland, Ohio, 44145
Ohio State University Medical Center
Columbus, Ohio, 43210
Duke University Medical Center
Durham, North Carolina, 27710
Meritcare Hospital
Fargo, North Dakota, 58122
Hartford Hospital
Hartford, Connecticut, 06102
Tennessee Heart and Vascular Inst.
Hendersonville, Tennessee, 37075
The Heart Center
Huntsville, Alabama, 35801
University of Florida - Jacksonville
Jacksonville, Florida, 32209
Scripps Center for Integrative Medicine
La Jolla, California, 92037
Cedars-Sinai Medical Center
Los Angeles, California, 90048
North Shore University Hospital
Manhasset, New York, 11030
Wisconsin Heart Hospital
Milwaukee, Wisconsin, 53226
Minneapolis Heart Inst.
Minneapolis, Minnesota, 55407
Yale - New Haven VA Hospital
New Haven, Connecticut, 06520
NYU Medical Center
New York, New York, 10016
Mount Sinai Medical Center
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, 73120
University of California Irvine Medical Center
Orange, California, 92868
Rhode Island Hospital
Providence, Rhode Island, 02903
Mayo Clinic
Rochester, Minnesota, 55902
St. Francis Hospital - The Heart Center
Roslyn, New York, 11576
Scottsdale Medical Imaging
Scottsdale, Arizona, 85252
University of Washington Cardiology & Nuclear Medicine
Seattle, Washington, 98195
Holy Name Hospital
Teaneck, New Jersey, 07666
Montefiore Medical Center
The Bronx, New York, 10461
Los Angeles Biomedical Research Inst.
Torrance, California, 90502
Cardiac Specialists
Trumbull, Connecticut, 06611
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: SPARC, Including Its Pilot CT Angiographic Study, is a Prospective, Open-label, Multicenter, Sequentially Sampled, Observational Registry to Define the Clinical Value of Stress Perfusion (Stress SPECT, Stress PET), Noninvasive Angiography (CTA) and Combined Perfusion-anatomy (PET/CT) Studies in Patients With Known or Suspected CAD With Respect to Post-test Resource Utilization and Prediction of Cardiac Death and Non-fatal Myocardial Infarction
Three main clinical outcomes will be assessed:
- Post-test resource utilization as assessed by referral rate to catheterization within 90-days of the index study;
- Incremental prognostic value and risk stratification for predicting cardiac death and myocardial infarction;
- Cost-effectiveness
Read more
To this end, SPARC is organized with two distinct specific objectives with important differences in patient population and endpoints.
Specific Aim 1: To evaluate the impact of stress perfusion imaging with SPECT or PET, CT Angiography, and hybrid PET-CT on post-test resource utilization.
The primary endpoint of specific aim 1 is to compare the impact of combined myocardial perfusion-coronary anatomy data to that of perfusion only [stress SPECT, stress cardiac PET (without CTA)] and anatomy only (CTA alone) on post-test resource utilization, as measured by referral to cardiac catheterization within 90 days of index noninvasive testing, in patients without CAD.
Secondary endpoints:
- to compare the diagnostic accuracy for detection of epicardial CAD of stress PET and hybrid PET-CT, stress SPECT, and CTA, as defined by coronary angiography;
- to compare the referral rate to revascularization within 90 days of cardiac catheterization.
Specific Aim 2: To compare the incremental prognostic value and risk stratification of stress perfusion imaging with SPECT or PET, CT coronary angiography, and combined perfusion-anatomy imaging approaches.
The primary endpoint of specific aim 2 is to compare the incremental value of stress perfusion only (stress PET and stress SPECT), coronary anatomy only (CTA data), and combined perfusion-anatomy studies (PET+CTA and SPECT+CTA) over clinical, historical and stress test data for the prediction of cardiac death and nonfatal myocardial infarction.
Secondary endpoints:
- to compare the incremental value of these noninvasive imaging approaches over clinical, historical and stress test data for the prediction of a composite endpoint including cardiac death, nonfatal myocardial infarction, late (>6 month from index study) referral to revascularization, or late (>6 month from index study) hospitalization for chest pain or heart failure;
- to compare the incremental value of these noninvasive imaging approaches over clinical, historical and stress test data for the prediction of all cause mortality. In addition, the ability of these modalities -together and separately- to risk stratify patients is a primary goal of specific aim 2.
- Keywords
- CORONARY ANATOMY, Coronary Artery Disease, SPECT, PET, PET/CT, CTA
- Medical subject headings
- Coronary Artery Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study startJun 2006
- Primary completionMar 2010
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Known CAD, or Intermediate-high Pretest Likelihood for CADStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- 3,019 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcelo F. Di Carli, MD, FACC, Brigham and Women's Hospital
- Investigators
- Marcelo F Di Carli, MD FACC, Principal investigator, Brigham and Women's HospitalRory Hachamovitch, MD Msc FACC, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00321399
- Sponsor's protocol ID
- SPARC
- Acronym
- SPARC
- Status last verified
- Jul 2014
- First submitted
- 1 May 2006
- Last updated
- 16 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Hachamovitch R, Nutter B, Hlatky MA, Shaw LJ, Ridner ML, Dorbala S, Beanlands RS, Chow BJ, Branscomb E, Chareonthaitawee P, Weigold WG, Voros S, Abbara S, Yasuda T, Jacobs JE, Lesser J, Berman DS, Thomson LE, Raman S, Heller GV, Schussheim A, Brunken R, Williams KA, Farkas S, Delbeke D, Schoepf UJ, Reichek N, Rabinowitz S, Sigman SR, Patterson R, Corn CR, White R, Kazerooni E, Corbett J, Bokhari S, Machac J, Guarneri E, Borges-Neto S, Millstine JW, Caldwell J, Arrighi J, Hoffmann U, Budoff M, Lima J, Johnson JR, Johnson B, Gaber M, Williams JA, Foster C, Hainer J, Di Carli MF; SPARC Investigators. Patient management after noninvasive cardiac imaging results from SPARC (Study of myocardial perfusion and coronary anatomy imaging roles in coronary artery disease). J Am Coll Cardiol. 2012 Jan 31;59(5):462-74. doi: 10.1016/j.jacc.2011.09.066.
PubMed 22281249Hachamovitch R, Johnson JR, Hlatky MA, Cantagallo L, Johnson BH, Coughlan M, Hainer J, Gierbolini J, Di Carli MF; SPARC Investigators. The study of myocardial perfusion and coronary anatomy imaging roles in CAD (SPARC): design, rationale, and baseline patient characteristics of a prospective, multicenter observational registry comparing PET, SPECT, and CTA for resource utilization and clinical outcomes. J Nucl Cardiol. 2009 Nov-Dec;16(6):935-48. doi: 10.1007/s12350-009-9140-7.
PubMed 19760338
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPARC, Including Its Pilot CT Angiographic Study, is a Prospective, Open-label, Multicenter, Sequentially Sampled, Observational Registry to Define the Clinical Value of Stress Perfusion (Stress SPECT, Stress PET), Noninvasive Angiography (CTA) and Combined Perfusion-anatomy (PET/CT) Studies in Patients With Known or Suspected CAD With Respect to Post-test Resource Utilization and Prediction of Cardiac Death and Non-fatal Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00321399
- Acronym / sponsor ID
- SPARC / SPARC
- Keywords
- CORONARY ANATOMY, Coronary Artery Disease, SPECT, PET, PET/CT, CTA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,019 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 3 May 2006 (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.
Three main clinical outcomes will be assessed:
- Post-test resource utilization as assessed by referral rate to catheterization within 90-days of the index study;
- Incremental prognostic value and risk stratification for predicting cardiac death and myocardial infarction;
- Cost-effectiveness
To this end, SPARC is organized with two distinct specific objectives with important differences in patient population and endpoints.
Specific Aim 1: To evaluate the impact of stress perfusion imaging with SPECT or PET, CT Angiography, and hybrid PET-CT on post-test resource utilization.
The primary endpoint of specific aim 1 is to compare the impact of combined myocardial perfusion-coronary anatomy data to that of perfusion only [stress SPECT, stress cardiac PET (without CTA)] and anatomy only (CTA alone) on post-test resource utilization, as measured by referral to cardiac catheterization within 90 days of index noninvasive testing, in patients without CAD.
Secondary endpoints:
- to compare the diagnostic accuracy for detection of epicardial CAD of stress PET and hybrid PET-CT, stress SPECT, and CTA, as defined by coronary angiography;
- to compare the referral rate to revascularization within 90 days of cardiac catheterization.
Specific Aim 2: To compare the incremental prognostic value and risk stratification of stress perfusion imaging with SPECT or PET, CT coronary angiography, and combined perfusion-anatomy imaging approaches.
The primary endpoint of specific aim 2 is to compare the incremental value of stress perfusion only (stress PET and stress SPECT), coronary anatomy only (CTA data), and combined perfusion-anatomy studies (PET+CTA and SPECT+CTA) over clinical, historical and stress test data for the prediction of cardiac death and nonfatal myocardial infarction.
Secondary endpoints:
- to compare the incremental value of these noninvasive imaging approaches over clinical, historical and stress test data for the prediction of a composite endpoint including cardiac death, nonfatal myocardial infarction, late (>6 month from index study) referral to revascularization, or late (>6 month from index study) hospitalization for chest pain or heart failure;
- to compare the incremental value of these noninvasive imaging approaches over clinical, historical and stress test data for the prediction of all cause mortality. In addition, the ability of these modalities -together and separately- to risk stratify patients is a primary goal of specific aim 2.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with known coronary artery disease and patients with suspected CAD and an intermediate-High Likelihood of disease
Key inclusion criteria (5 listed)
- Referred for a clinical stress SPECT, stress PET, CTA or PET-CT study
- Intermediate to high pretest likelihood for CAD (>.25;as defined by ACC/AHA Stable Angina Guidelines) without prior MI/PCI/CABG. These are considered diagnostic patients.
- or
- Documented known CAD as defined by prior MI/PCI/CABG
- Provide signed informed consent to participate in the study
Key exclusion criteria (6 listed)
- Low pretest likelihood for CAD (<=.25; as defined by ACC/AHA Stable Angina Guidelines).
- Major concomitant noncardiac disease or social condition/situation that in the opinion of the investigator will preclude the patient from participation in the study follow-up.
- Concurrent or prior(within last 30 days) participation in other research studies using investigational drugs or devices.
- Presence of a permanent automated internal cardiac defibrillator (AICD)
- Known non-ischemic cardiomyopathy
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 16 Jul 2014.
- Derived from this study: PubMed 22281249Hachamovitch R, Nutter B, Hlatky MA, Shaw LJ, Ridner ML, Dorbala S, Beanlands RS, Chow BJ, Branscomb E, Chareonthaitawee P, Weigold WG, Voros S, Abbara S, Yasuda T, Jacobs JE, Lesser J, Berman DS, Thomson LE, Raman S, Heller GV, Schussheim A, Brunken R, Williams KA, Farkas S, Delbeke D, Schoepf UJ, Reichek N, Rabinowitz S, Sigman SR, Patterson R, Corn CR, White R, Kazerooni E, Corbett J, Bokhari S, Machac J, Guarneri E, Borges-Neto S, Millstine JW, Caldwell J, Arrighi J, Hoffmann U, Budoff M, Lima J, Johnson JR, Johnson B, Gaber M, Williams JA, Foster C, Hainer J, Di Carli MF; SPARC Investigators. Patient management after noninvasive cardiac imaging results from SPARC (Study of myocardial perfusion and coronary anatomy imaging roles in coronary artery disease). J Am Coll Cardiol. 2012 Jan 31;59(5):462-74. doi: 10.1016/j.jacc.2011.09.066.
- Derived from this study: PubMed 19760338Hachamovitch R, Johnson JR, Hlatky MA, Cantagallo L, Johnson BH, Coughlan M, Hainer J, Gierbolini J, Di Carli MF; SPARC Investigators. The study of myocardial perfusion and coronary anatomy imaging roles in CAD (SPARC): design, rationale, and baseline patient characteristics of a prospective, multicenter observational registry comparing PET, SPECT, and CTA for resource utilization and clinical outcomes. J Nucl Cardiol. 2009 Nov-Dec;16(6):935-48. doi: 10.1007/s12350-009-9140-7.
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.
Marcelo F Di Carli, MD FACC principal investigator
Brigham and Women's Hospital
Rory Hachamovitch, MD Msc FACC principal investigator
University of Southern California
41 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Known CAD, or Intermediate-high Pretest Likelihood for CAD, run by Brigham and Women's Hospital at 41 sites in 2 countries.
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 6 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 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Canada. 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 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?
On the ClinicalTrials.gov record for NCT00321399, which also lists 2 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 16 Jul 2014; AzTrials last refreshed its copy on 8 Nov 2026.