Nordic Consortium for Acute Type a Aortic Dissection-2

NCT06862583 | Recruiting

• 1 other identifier: 2019-02087
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

The Nordic Consortium for Acute Type A Aortic Dissection-2 (NORCAAD-2) is a multicenter research collaboration involving up to 19 units in the Nordic countries and one in The Netherlands. All patients referred for this condition is included, to outline detailed preoperative characteristics and risk factors as well as, for those operated, data on the operative procedure, the postoperative course including major and minor complications and, as the primary interest, mortality in short- and long-term perspective. The need for further procedures on the aorta will also be studied. Acute type A Aortic Dissection (ATAAD) is a vascular emergency with very high case-fatality rate. The condition is realtively infrequent, and single units can rarely amass sufficient number of patients during a reasonable time to analyse also unusual variants in background, presentation, and management. Randomized controlled trials are unlikely, and large multicenter databases are the best source of knowledge for the foreseeable future. Other such databases exist, but NORCAAD-2 is more focused (only ATAAD) and more detailed than many counterparts, with the ability to extract unique information. NORCAAD-2 is the extension and expansion of the original NORCAAD project. NORCAAD-2 includes more centers, more patients, more data and utilizes a novel on-line common database designed for the purpose. The ultimate goal is to identify novel risk markers to help inform decisions on pre-emptive surgery (before ATAAD occurs); to outline superior perioperative techniques and strategies to optimize outcomes both short- and long-term; and to analyze variables related to major complications, in an effort to further reduce their incidence.

Conditions

Aortic Dissection

Keywords

Open surgery; Risk factors; Outcomes; Mortality; Circulatory arrest; cerebral protection; bicuspid aortic valve

Outcome Measures

Primary Outcomes (1)

• Early mortality

  Mortality within 30 days of referral or operation

  30 days

Secondary Outcomes (2)

• Late mortality

  >30 days

• Reintervention

  throughout study period

Other Outcomes (4)

• Permanent neurological damage

  30 days

• Temporary neurological damage

  30 days

• Renal insufficiency

  30 days

Interventions

surgery PROCEDURE

Open heart surgery

endovascular intervention PROCEDURE

Aortic endovascular intervention

Eligibility Criteria

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

Study Population

All patients with acute type A aortic dissection referred to any of the participating centers

You may qualify if:

• Acute (within 14 days of onset) type A aortic dissection or similar acute aortic syndrome

You may not qualify if:

• Age \<18 years at onset

Sponsors & Collaborators

• Karolinska Institutet: lead
• Aarhus University Hospital Skejby: collaborator
• Haukeland University Hospital: collaborator
• Rigshospitalet, Denmark: collaborator
• Helsinki University Central Hospital: collaborator
• Kuopio University Hospital: collaborator
• Leiden University Medical Center: collaborator
• Skane University Hospital: collaborator
• Odense University Hospital: collaborator
• Oslo University Hospital: collaborator
• Landspitali University Hospital: collaborator
• Norrlands University Hospital: collaborator
• Tampere University Hospital: collaborator
• Turku University Hospital: collaborator
• Trondheim University Hospital: collaborator
• University Hospital, Linkoeping: collaborator
• Vastra Gotaland Region: collaborator
• Uppsala University Hospital: collaborator
• Blekinge County Council Hospital: collaborator
• Örebro University, Sweden: collaborator

Study Sites (1)

Karolinska Institute

Stockholm, SE17177, Sweden

RECRUITING

Related Publications (12)

• Eleid MF, Forde I, Edwards WD, Maleszewski JJ, Suri RM, Schaff HV, Enriquez-Sarano M, Michelena HI. Type A aortic dissection in patients with bicuspid aortic valves: clinical and pathological comparison with tricuspid aortic valves. Heart. 2013 Nov;99(22):1668-74. doi: 10.1136/heartjnl-2013-304606. Epub 2013 Sep 4.

  PMID: 24006455 BACKGROUND

• Myrmel T, Lai DT, Miller DC. Can the principles of evidence-based medicine be applied to the treatment of aortic dissections? Eur J Cardiothorac Surg. 2004 Feb;25(2):236-42; discussion 242-5. doi: 10.1016/j.ejcts.2003.11.022.

  PMID: 14747119 BACKGROUND

• Geirsson A, Ahlsson A, Franco-Cereceda A, Fuglsang S, Gunn J, Hansson EC, Hjortdal V, Jarvela K, Jeppsson A, Mennander A, Nozohoor S, Olsson C, Wickbom A, Zindovic I, Gudbjartsson T. The Nordic Consortium for Acute type A Aortic Dissection (NORCAAD): objectives and design. Scand Cardiovasc J. 2016 Oct-Dec;50(5-6):334-340. doi: 10.1080/14017431.2016.1235284. Epub 2016 Sep 26.

  PMID: 27615395 BACKGROUND

• Hiratzka LF, Bakris GL, Beckman JA, Bersin RM, Carr VF, Casey DE Jr, Eagle KA, Hermann LK, Isselbacher EM, Kazerooni EA, Kouchoukos NT, Lytle BW, Milewicz DM, Reich DL, Sen S, Shinn JA, Svensson LG, Williams DM; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; American College of Radiology; American Stroke Association; Society of Cardiovascular Anesthesiologists; Society for Cardiovascular Angiography and Interventions; Society of Interventional Radiology; Society of Thoracic Surgeons; Society for Vascular Medicine. 2010 ACCF/AHA/AATS/ACR/ASA/SCA/SCAI/SIR/STS/SVM Guidelines for the diagnosis and management of patients with thoracic aortic disease. A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, American Association for Thoracic Surgery, American College of Radiology,American Stroke Association, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of Thoracic Surgeons,and Society for Vascular Medicine. J Am Coll Cardiol. 2010 Apr 6;55(14):e27-e129. doi: 10.1016/j.jacc.2010.02.015. No abstract available.

  PMID: 20359588 BACKGROUND

• Authors/Task Force Members; Czerny M, Grabenwoger M, Berger T, Aboyans V, Della Corte A, Chen EP, Desai ND, Dumfarth J, Elefteriades JA, Etz CD, Kim KM, Kreibich M, Lescan M, Di Marco L, Martens A, Mestres CA, Milojevic M, Nienaber CA, Piffaretti G, Preventza O, Quintana E, Rylski B, Schlett CL, Schoenhoff F, Trimarchi S, Tsagakis K; EACTS/STS Scientific Document Group; Siepe M, Estrera AL, Bavaria JE, Pacini D, Okita Y, Evangelista A, Harrington KB, Kachroo P, Hughes GC. EACTS/STS Guidelines for Diagnosing and Treating Acute and Chronic Syndromes of the Aortic Organ. Ann Thorac Surg. 2024 Jul;118(1):5-115. doi: 10.1016/j.athoracsur.2024.01.021. Epub 2024 Feb 26. No abstract available.

  PMID: 38416090 BACKGROUND

• Mazzolai L, Teixido-Tura G, Lanzi S, Boc V, Bossone E, Brodmann M, Bura-Riviere A, De Backer J, Deglise S, Della Corte A, Heiss C, Kaluzna-Oleksy M, Kurpas D, McEniery CM, Mirault T, Pasquet AA, Pitcher A, Schaubroeck HAI, Schlager O, Sirnes PA, Sprynger MG, Stabile E, Steinbach F, Thielmann M, van Kimmenade RRJ, Venermo M, Rodriguez-Palomares JF; ESC Scientific Document Group. 2024 ESC Guidelines for the management of peripheral arterial and aortic diseases. Eur Heart J. 2024 Sep 29;45(36):3538-3700. doi: 10.1093/eurheartj/ehae179. No abstract available.

  PMID: 39210722 BACKGROUND

• Girdauskas E, Disha K, Borger MA, Kuntze T. Risk of proximal aortic dissection in patients with bicuspid aortic valve: how to address this controversy? Interact Cardiovasc Thorac Surg. 2014 Mar;18(3):355-9. doi: 10.1093/icvts/ivt518. Epub 2013 Dec 12.

  PMID: 24336701 BACKGROUND

• Conzelmann LO, Weigang E, Mehlhorn U, Abugameh A, Hoffmann I, Blettner M, Etz CD, Czerny M, Vahl CF; GERAADA Investigators. Mortality in patients with acute aortic dissection type A: analysis of pre- and intraoperative risk factors from the German Registry for Acute Aortic Dissection Type A (GERAADA). Eur J Cardiothorac Surg. 2016 Feb;49(2):e44-52. doi: 10.1093/ejcts/ezv356. Epub 2015 Oct 28.

  PMID: 26510701 BACKGROUND

• Evangelista A, Isselbacher EM, Bossone E, Gleason TG, Eusanio MD, Sechtem U, Ehrlich MP, Trimarchi S, Braverman AC, Myrmel T, Harris KM, Hutchinson S, O'Gara P, Suzuki T, Nienaber CA, Eagle KA; IRAD Investigators. Insights From the International Registry of Acute Aortic Dissection: A 20-Year Experience of Collaborative Clinical Research. Circulation. 2018 Apr 24;137(17):1846-1860. doi: 10.1161/CIRCULATIONAHA.117.031264.

  PMID: 29685932 BACKGROUND

• Howard DP, Banerjee A, Fairhead JF, Perkins J, Silver LE, Rothwell PM; Oxford Vascular Study. Population-based study of incidence and outcome of acute aortic dissection and premorbid risk factor control: 10-year results from the Oxford Vascular Study. Circulation. 2013 May 21;127(20):2031-7. doi: 10.1161/CIRCULATIONAHA.112.000483. Epub 2013 Apr 18.

  PMID: 23599348 BACKGROUND

• Olsson C, Thelin S, Stahle E, Ekbom A, Granath F. Thoracic aortic aneurysm and dissection: increasing prevalence and improved outcomes reported in a nationwide population-based study of more than 14,000 cases from 1987 to 2002. Circulation. 2006 Dec 12;114(24):2611-8. doi: 10.1161/CIRCULATIONAHA.106.630400. Epub 2006 Dec 4.

  PMID: 17145990 BACKGROUND

• Melvinsdottir IH, Lund SH, Agnarsson BA, Sigvaldason K, Gudbjartsson T, Geirsson A. The incidence and mortality of acute thoracic aortic dissection: results from a whole nation study. Eur J Cardiothorac Surg. 2016 Dec;50(6):1111-1117. doi: 10.1093/ejcts/ezw235. Epub 2016 Jun 22.

  PMID: 27334108 BACKGROUND

MeSH Terms

Conditions

Aortic Dissection; Bicuspid Aortic Valve Disease

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Diseases; Aortic Valve Disease; Heart Valve Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Christian Olsson, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Olsson, MD, PhD

CONTACT

+46812370000; christian.olsson@ki.se

Markus Bjurbom, MD

CONTACT

+46812370000; markus.bjurbom@ki.se

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: March 6, 2025
• Study Start: June 3, 2019
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)