CRAGS (Coronary aRtery diseAse in younG adultS)

NCT01838746 | Unknown

• 1 other identifier: CRAGS-1
• Study Type: observational
• Target: 2,000
• Locations: 4 countries
• Sites: 9

Brief Summary

Young patients requiring myocardial revascularization are generally considered at low operative risk, but data on their immediate and late outcome are scarce. The decision-making process in these young patients is complicated by the potentially aggressive nature of premature coronary artery disease and their likely long expectancy of life, which expose them to a significantly higher risk of recurrent coronary events as well as the need of repeat revascularization. The lack of data on long-term outcome as well as on operative details (in particular, on the use of arterial grafts) and peri- and postoperative medication prevent any conclusive results on the durability either of coronary artery bypass grafting (CABG) or of percutaneous coronary intervention (PCI) in these young patients. Furthermore, recent advances in stents technology as well in peri- and postoperative medical treatment indicate the need a comparative study to define the baseline characteristics of patients aged \< 50 years undergoing either PCI or CABG and to evaluate their current immediate and late outcome.

Conditions

Coronary Artery Disease; Acute Coronary Syndromes; Young Patient; Percutaneous Coronary Intervention; Coronary Artery Bypass Grafting

Keywords

Percutaneous coronary intervention; Coronary artery bypass grafting; Coronary artery bypass surgery; Survival; Acute coronary syndrome; ST segment elevation myocardial infarction; Non-ST segment elevation myocardial infarction; Younge patient

Outcome Measures

Primary Outcomes (1)

• Repeat revascularization

  Any percutaneous coronary intervention or coronary artery bypass grafting after primary revascularization

  Three years

Secondary Outcomes (4)

• All-cause mortality

  Three years

• Major cardiovascular and cerebral events (MACCE)

  Three years

• Stroke

  Three years

• Myocardial infarction

  Three years

Study Arms (2)

PCI

Patients undergoing PCI

CABG

Patients undergoing CABG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged \< 50 years who underwent CABG or PCI from 2005 to 2012 will be collected from multiple institutions.

You may qualify if:

• \- age \< 50

You may not qualify if:

• age \> 50

Sponsors & Collaborators

• University of Turku: lead
• Finnish Foundation for Cardiovascular Research: collaborator

Study Sites (9)

Oulu University Hospital

Oulu, Finland

Location

Satakunta Central Hospital

Pori, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Turku University Hospital

Turku, Finland

Location

Vaasa Central Hospital

Vaasa, Finland

Location

University of Iceland

Reykjavik, Iceland

Location

University of Catania

Catania, Italy

Location

University of Verona Medical School

Verona, Italy

Location

Sahlgrenska Hospital

Gothenburg, Sweden

Location

Related Publications (9)

• Gunn J, Kuttila K, Vasques F, Virtanen R, Lahti A, Airaksinen J, Biancari F. Comparison of results of coronary artery bypass grafting versus percutaneous coronary intervention in octogenarians. Am J Cardiol. 2012 Oct 15;110(8):1125-9. doi: 10.1016/j.amjcard.2012.05.055. Epub 2012 Jul 3.

  PMID: 22762714 BACKGROUND

• Nissinen J, Wistbacka JO, Loponen P, Korpilahti K, Teittinen K, Virkkila M, Tarkka M, Biancari F. Coronary artery bypass surgery in octogenarians: long-term outcome can be better than expected. Ann Thorac Surg. 2010 Apr;89(4):1119-24. doi: 10.1016/j.athoracsur.2009.12.063.

  PMID: 20338317 BACKGROUND

• Kappetein AP, Feldman TE, Mack MJ, Morice MC, Holmes DR, Stahle E, Dawkins KD, Mohr FW, Serruys PW, Colombo A. Comparison of coronary bypass surgery with drug-eluting stenting for the treatment of left main and/or three-vessel disease: 3-year follow-up of the SYNTAX trial. Eur Heart J. 2011 Sep;32(17):2125-34. doi: 10.1093/eurheartj/ehr213. Epub 2011 Jun 22.

  PMID: 21697170 BACKGROUND

• Locker C, Schaff HV, Dearani JA, Joyce LD, Park SJ, Burkhart HM, Suri RM, Greason KL, Stulak JM, Li Z, Daly RC. Multiple arterial grafts improve late survival of patients undergoing coronary artery bypass graft surgery: analysis of 8622 patients with multivessel disease. Circulation. 2012 Aug 28;126(9):1023-30. doi: 10.1161/CIRCULATIONAHA.111.084624. Epub 2012 Jul 18.

  PMID: 22811577 BACKGROUND

• Cole JH, Miller JI 3rd, Sperling LS, Weintraub WS. Long-term follow-up of coronary artery disease presenting in young adults. J Am Coll Cardiol. 2003 Feb 19;41(4):521-8. doi: 10.1016/s0735-1097(02)02862-0.

  PMID: 12598059 BACKGROUND

• Canver CC, Nichols RD, Cooler SD, Heisey DM, Murray EL, Kroncke GM. Influence of increasing age on long-term survival after coronary artery bypass grafting. Ann Thorac Surg. 1996 Oct;62(4):1123-7. doi: 10.1016/0003-4975(96)00446-8.

  PMID: 8823100 BACKGROUND

• Ellis CJ, French JK, White HD, Ormiston JA, Whitlock RM, Webster MW. Results of percutaneous coronary angioplasty in patients <40 years of age. Am J Cardiol. 1998 Jul 15;82(2):135-9. doi: 10.1016/s0002-9149(98)00318-x.

  PMID: 9678280 BACKGROUND

• Lautamaki A, Airaksinen KE, Kiviniemi T, Vinco G, Ribichini F, Gunn J, Anttila V, Heikkinen J, Korpilahti K, Karjalainen P, Kajander O, Eskola M, Ilveskoski E, Axelsson T, Gudbjartsson T, Jeppsson A, Biancari F. Prognosis and disease progression in patients under 50 years old undergoing PCI: the CRAGS (Coronary aRtery diseAse in younG adultS) study. Atherosclerosis. 2014 Aug;235(2):483-7. doi: 10.1016/j.atherosclerosis.2014.05.953. Epub 2014 Jun 9.

  PMID: 24953487 DERIVED

• Biancari F, Gudbjartsson T, Heikkinen J, Anttila V, Makikallio T, Jeppsson A, Thimour-Bergstrom L, Mignosa C, Rubino AS, Kuttila K, Gunn J, Wistbacka JO, Teittinen K, Korpilahti K, Onorati F, Faggian G, Vinco G, Vassanelli C, Ribichini F, Juvonen T, Axelsson TA, Sigurdsson AF, Karjalainen PP, Mennander A, Kajander O, Eskola M, Ilveskoski E, D'Oria V, De Feo M, Kiviniemi T, Airaksinen KE. Comparison of 30-day and 5-year outcomes of percutaneous coronary intervention versus coronary artery bypass grafting in patients aged</=50 years (the Coronary aRtery diseAse in younG adultS Study). Am J Cardiol. 2014 Jul 15;114(2):198-205. doi: 10.1016/j.amjcard.2014.04.025. Epub 2014 May 2.

  PMID: 24878127 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome; ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Fausto Biancari, MD, PhD

  Oulu University Hospital

  PRINCIPAL INVESTIGATOR

• Juhani Airaksinen, MD, PhD

  Turku University Hospital

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: April 24, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2016
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

IC (1); SE (1); IT (2); FI (5)