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Comparison of Cardiac Imaging Techniques for Diagnosing Coronary Artery Disease (PACIFIC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by VU University Medical Center
Sponsor:
Information provided by (Responsible Party):
Paul Knaapen, VU University Medical Center
ClinicalTrials.gov Identifier:
NCT01521468
First received: January 25, 2012
Last updated: March 7, 2012
Last verified: March 2012
  Purpose

A large number of cardiac catheterizations are performed each year, primarily to diagnose heart disease. However, a cardiac catheterization is an invasive procedure which is associated with serious complications such as heart infarction, stroke, and death. Therefore, there is a need for non-invasive procedures to diagnose coronary heart disease. The purpose of this study is, therefore, to assess the diagnostic accuracy of non-invasive cardiac imaging modalities for the detection of heart disease in patients presenting for the first time to the cardiologist with chest pain.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Comparison of Cardiac PET/CT, SPECT/CT Perfusion Imaging and CT Coronary Angiography With Invasive Coronary Angiography

Further study details as provided by VU University Medical Center:

Primary Outcome Measures:
  • Head to head comparison between hybrid SPECT/CTCA and PET/CTCA [ Time Frame: Invasive coronary angiography + fractional flow reserve measurements within 1 week of the initial scans ] [ Designated as safety issue: No ]
    A head-to-head comparison will be performed to assess the diagnostic accuracy of stress hybrid PET/CTCA and hybrid SPECT/CTCA for the detection of obstructive coronary artery disease as defined by invasive coronary angiography in combination with fractional flow reserve measurements.

  • Non-invasive imaging for risk stratification [ Time Frame: Ten years ] [ Designated as safety issue: No ]
    To determine the prognostic value of CTCA, SPECT, quantitative PET, hybrid SPECT/CTCA and PET/CTCA for predicting cardiac death and nonfatal myocardial infarction.

  • Improving prognostication [ Time Frame: Ten years ] [ Designated as safety issue: No ]
    To compare the ability and incremental value of non-invasive stand-alone and cardiac hybrid imaging over clinical, historical and exercise test data for the prediction of all cause mortality.

  • Diagnostic accuracy of CTCA, SPECT and PET [ Time Frame: Invasive coronary angiography + fractional flow reserve measurements within 1 week of the initial scans ] [ Designated as safety issue: No ]
    Determining the diagnostic accuracy of stand-alone cardiac imaging modalities


Secondary Outcome Measures:
  • Risk stratification [ Time Frame: Ten years ] [ Designated as safety issue: No ]
    To determine the incremental prognostic value of several biomarkers over non-invasive imaging, clinical, historical and exercise test data to predict overall mortality, nonfatal myocardial infarction, revascularization and hospitalization for chest pain or heart failure.

  • Risk stratification [ Time Frame: > 6 months ] [ Designated as safety issue: No ]
    To compare the predictive and incremental value of stand-alone and cardiac hybrid imaging imaging over clinical, historical and exercise test data for the prediction of a composite endpoint including cardiac death, nonfatal myocardial infarction, late referral to revascularization, or late hospitalization for chest pain or heart failure.

  • Risk stratification [ Time Frame: > 6 months ] [ Designated as safety issue: No ]
    To compare the predictive and incremental value of several biomarkers over non-invasive imaging, clinical, historical and exercise test data for the prediction of a composite endpoint including cardiac death, nonfatal myocardial infarction, late referral to revascularization, or late hospitalization for chest pain or heart failure.


Biospecimen Retention:   Samples With DNA

Urine and whole blood.


Estimated Enrollment: 210
Study Start Date: January 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Outpatient clinic of the VU University Medical Center hospital in Amsterdam.

Criteria

Inclusion Criteria:

  • First presentation to cardiologist with suspected coronary artery disease
  • No documented prior history of coronary artery disease
  • Intermediate pre-test likelihood for coronary artery disease as defined by Diamond and Forrester criteria
  • Clinically referred for invasive coronary angiography
  • Age above 40 years

Exclusion Criteria:

  • History of severe COPD or chronic asthma
  • Pregnancy
  • Renal failure ( i.e. eGFR < 45ml/min)
  • Use of sildenafil (Viagra) or dipyramidol (Persantin) that can not be terminated.
  • Contra-indications for β-blockers
  • Allergic reaction to iodized contrast
  • Concurrent or prior (within last 30 days) participation in other research studies using investigational drugs
  • Claustrophobia
  • Significant co-morbidities
  • Atrial fibrillation, second or third degree atrioventricular block
  • Tachycardia
  • Acute myocardial infarction
  • Heart failure
  • Left ventricle ejection fraction estimated < 50%
  • Cardiomyopathies
  • Previous radiation exposure in the diagnostic work-up
  • Subjects intended for short-term medical treatment or an invasive coronary intervention
  • No informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01521468

Contacts
Contact: Ibrahim Danad, MD +31 20 4443262 i.danad@vumc.nl

Locations
Netherlands
VU University Medical Center Recruiting
Amsterdam, Netherlands, 1081 HV
Sub-Investigator: Ibrahim Danad, MD         
Sub-Investigator: Pieter G Raijmakers, MD, PhD         
Sub-Investigator: Otto S Hoekstra, MD, PhD         
Sub-Investigator: Albert C van Rossum, MD, PhD         
Sub-Investigator: Cornelis van Kuijk, MD, PhD         
Sponsors and Collaborators
VU University Medical Center
Investigators
Principal Investigator: Paul Knaapen, MD, PhD VU University Medical Center, ICaR-VU
  More Information

Publications:

Responsible Party: Paul Knaapen, MD, PhD, VU University Medical Center
ClinicalTrials.gov Identifier: NCT01521468     History of Changes
Other Study ID Numbers: NL33941.029.10, 2011/209
Study First Received: January 25, 2012
Last Updated: March 7, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by VU University Medical Center:
Coronary artery disease
Diagnostic accuracy
CT coronary angiography
Positron emission tomography
Single photon emission tomography
Noninvasive techniques
Cardiac catheterization
Fractional flow reserve

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014