Comparison of Cardiac Imaging Techniques for Diagnosing Coronary Artery Disease

NCT01521468 | Completed DMC

• 2 other identifiers: NL33941.029.102011/209
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; Diagnostic accuracy; CT coronary angiography; Positron emission tomography; Single photon emission tomography; Noninvasive techniques; Cardiac catheterization; Fractional flow reserve

Outcome Measures

Primary Outcomes (4)

• Head to head comparison between hybrid SPECT/CTCA and PET/CTCA

  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.

  Invasive coronary angiography + fractional flow reserve measurements within 1 week of the initial scans

• Non-invasive imaging for risk stratification

  To determine the prognostic value of CTCA, SPECT, quantitative PET, hybrid SPECT/CTCA and PET/CTCA for predicting cardiac death and nonfatal myocardial infarction.

  Ten years

• Improving prognostication

  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.

  Ten years

• Diagnostic accuracy of CTCA, SPECT and PET

  Determining the diagnostic accuracy of stand-alone cardiac imaging modalities

  Invasive coronary angiography + fractional flow reserve measurements within 1 week of the initial scans

Secondary Outcomes (3)

• Risk stratification

  Ten years

• Risk stratification

  > 6 months

• Risk stratification

  > 6 months

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• History of severe chronic obstructive pulmonary disease (COPD) or chronic asthma
• Pregnancy
• Renal failure ( i.e. estimated glomerular filtration rate \< 45 mL/min)
• Use of sildenafil (Viagra) or dipyridamole (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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

VU University Medical Center

Amsterdam, 1081 HV, Netherlands

Location

Related Publications (14)

• Kajander S, Joutsiniemi E, Saraste M, Pietila M, Ukkonen H, Saraste A, Sipila HT, Teras M, Maki M, Airaksinen J, Hartiala J, Knuuti J. Cardiac positron emission tomography/computed tomography imaging accurately detects anatomically and functionally significant coronary artery disease. Circulation. 2010 Aug 10;122(6):603-13. doi: 10.1161/CIRCULATIONAHA.109.915009. Epub 2010 Jul 26.

  PMID: 20660808 BACKGROUND

• Di Carli MF, Hachamovitch R. New technology for noninvasive evaluation of coronary artery disease. Circulation. 2007 Mar 20;115(11):1464-80. doi: 10.1161/CIRCULATIONAHA.106.629808. No abstract available.

  PMID: 17372188 BACKGROUND

• Gaemperli O, Husmann L, Schepis T, Koepfli P, Valenta I, Jenni W, Alkadhi H, Luscher TF, Kaufmann PA. Coronary CT angiography and myocardial perfusion imaging to detect flow-limiting stenoses: a potential gatekeeper for coronary revascularization? Eur Heart J. 2009 Dec;30(23):2921-9. doi: 10.1093/eurheartj/ehp304. Epub 2009 Aug 14.

  PMID: 19684023 BACKGROUND

• Schuijf JD, Wijns W, Jukema JW, Atsma DE, de Roos A, Lamb HJ, Stokkel MP, Dibbets-Schneider P, Decramer I, De Bondt P, van der Wall EE, Vanhoenacker PK, Bax JJ. Relationship between noninvasive coronary angiography with multi-slice computed tomography and myocardial perfusion imaging. J Am Coll Cardiol. 2006 Dec 19;48(12):2508-14. doi: 10.1016/j.jacc.2006.05.080. Epub 2006 Nov 28.

  PMID: 17174190 BACKGROUND

• Knaapen P, de Haan S, Hoekstra OS, Halbmeijer R, Appelman YE, Groothuis JG, Comans EF, Meijerink MR, Lammertsma AA, Lubberink M, Gotte MJ, van Rossum AC. Cardiac PET-CT: advanced hybrid imaging for the detection of coronary artery disease. Neth Heart J. 2010 Feb;18(2):90-8. doi: 10.1007/BF03091744.

  PMID: 20200615 BACKGROUND

• Pijls NH, De Bruyne B, Peels K, Van Der Voort PH, Bonnier HJ, Bartunek J Koolen JJ, Koolen JJ. Measurement of fractional flow reserve to assess the functional severity of coronary-artery stenoses. N Engl J Med. 1996 Jun 27;334(26):1703-8. doi: 10.1056/NEJM199606273342604.

  PMID: 8637515 BACKGROUND

• Levin DC. Invasive evaluation (coronary arteriography) of the coronary artery disease patient: clinical, economic and social issues. Circulation. 1982 Nov;66(5 Pt 2):III71-9.

  PMID: 7127709 BACKGROUND

• Pazhenkottil AP, Nkoulou RN, Ghadri JR, Herzog BA, Kuest SM, Husmann L, Wolfrum M, Goetti R, Buechel RR, Gaemperli O, Luscher TF, Kaufmann PA. Impact of cardiac hybrid single-photon emission computed tomography/computed tomography imaging on choice of treatment strategy in coronary artery disease. Eur Heart J. 2011 Nov;32(22):2824-9. doi: 10.1093/eurheartj/ehr232. Epub 2011 Jul 30.

  PMID: 21804107 BACKGROUND

• Gaemperli O, Bengel FM, Kaufmann PA. Cardiac hybrid imaging. Eur Heart J. 2011 Sep;32(17):2100-8. doi: 10.1093/eurheartj/ehr057. Epub 2011 Mar 15.

  PMID: 21406437 BACKGROUND

• Pazhenkottil AP, Nkoulou RN, Ghadri JR, Herzog BA, Buechel RR, Kuest SM, Wolfrum M, Fiechter M, Husmann L, Gaemperli O, Kaufmann PA. Prognostic value of cardiac hybrid imaging integrating single-photon emission computed tomography with coronary computed tomography angiography. Eur Heart J. 2011 Jun;32(12):1465-71. doi: 10.1093/eurheartj/ehr047. Epub 2011 Feb 14.

  PMID: 21320906 BACKGROUND

• Wilgenhof A, Jukema RA, Driessen RS, Danad I, Raijmakers PG, van Royen N, van Nunen LX, Collet C, de Waard GA, Knaapen P. The effect of hydrostatic pressure on invasive coronary pressure measurements: Comparison with [15O]H2O-positron emission tomography flow data. Catheter Cardiovasc Interv. 2024 Nov;104(5):980-989. doi: 10.1002/ccd.31215. Epub 2024 Sep 11.

  PMID: 39258435 DERIVED

• Arai AE. Why Should We Quantify Stress Myocardial Perfusion CMR? JACC Cardiovasc Imaging. 2024 Mar;17(3):266-268. doi: 10.1016/j.jcmg.2023.08.015. Epub 2023 Oct 18. No abstract available.

  PMID: 37855801 DERIVED

• Lin A, van Diemen PA, Motwani M, McElhinney P, Otaki Y, Han D, Kwan A, Tzolos E, Klein E, Kuronuma K, Grodecki K, Shou B, Rios R, Manral N, Cadet S, Danad I, Driessen RS, Berman DS, Norgaard BL, Slomka PJ, Knaapen P, Dey D. Machine Learning From Quantitative Coronary Computed Tomography Angiography Predicts Fractional Flow Reserve-Defined Ischemia and Impaired Myocardial Blood Flow. Circ Cardiovasc Imaging. 2022 Oct;15(10):e014369. doi: 10.1161/CIRCIMAGING.122.014369. Epub 2022 Oct 13.

  PMID: 36252116 DERIVED

• de Waard GA, Danad I, Petraco R, Driessen RS, Raijmakers PG, Teunissen PF, van de Ven PM, van Leeuwen MAH, Nap A, Harms HJ, Lammertsma AA, Davies JE, Knaapen P, van Royen N. Fractional flow reserve, instantaneous wave-free ratio, and resting Pd/Pa compared with [15O]H2O positron emission tomography myocardial perfusion imaging: a PACIFIC trial sub-study. Eur Heart J. 2018 Dec 7;39(46):4072-4081. doi: 10.1093/eurheartj/ehy632.

  PMID: 30452609 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Urine and whole blood.

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Paul Knaapen, MD, PhD

  VU University Medical Center, ICaR-VU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 25, 2012
• First Posted: January 30, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 10, 2014

Record last verified: 2014-12

Locations

NL (1)