Clinical trial NCT01435408: DANish Study of Optimal Acute Treatment of Patients With ST-elevation Myocardial Infarction
Official title: A Randomised Comparison of the Clinical Outcome After Postconditioning or Deferred Stent Implantation Versus Conventional Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ST Segment Elevation Myocardial Infarction
Keywords: STEMI
Ischemic postconditioning
Deferred stenting
Primary PCI
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2011-09-16
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study focuses on Cardioprotective strategies.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Acute onset of chest pain of \< 12 hours' duration.
* ST-segment elevation ≥ 0.1 mV in ≥ 2 contiguous leads, signs of a true posterior infarction or documented newly developed left bundle branch block.

Culprit lesion in a major native vessel.

Exclusion Criteria:

* Pregnancy.
* Known intolerance of ASA, clopidogrel, heparin or contrast.
* Inability to understand information or to provide informed consent.
* Haemorrhagic diathesis or known coagulopathy.
* Stent thrombosis.

Primary outcomes:
measure: All cause mortality, heart failure (postconditioning)
timeFrame: 2 years
Secondary outcomes:
measure: Infarct size in relation to area at risk as determined by MRI after 3 month
timeFrame: 3 month
measure: All cause mortality, myocardial infarction, repeat revascularisation and occurrence of definite stent thrombosis according to ARC definition within 1 year (deferred stent strategy)
timeFrame: 1 year
Other outcomes:
measure: TIMI flow
timeFrame: postprocedure
measure: ST-segment resolution
timeFrame: 90 min postprocedure
measure: Wall motion index (echo)
timeFrame: 1 year
measure: LVEF (MRI)
timeFrame: 90 days
measure: Infarct size (MRI)
timeFrame: 90 days
measure: Microvascular obstruction (MVO)
timeFrame: within 48 hours
measure: Quality of life
timeFrame: 1 year
Locations:
city: Aalborg
country: Denmark
facility: Department of Cardiology, Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Department of Cardiology, Skejby University Hospital
city: Copenhagen
country: Denmark
facility: The Heart Center, Rigshospitalet, University of Copenhagen
city: Hellerup
country: Denmark
facility: Department of Cardiology, Gentofte University Hospital
city: Odense
country: Denmark
facility: Department of Cardiology, Odense University Hospital
Study officials:
affiliation: The Heart Center, Rigshospitalet, University of Copenhagen
name: Lars Koeber, Prof., DMSci
role: PRINCIPAL_INVESTIGATOR
affiliation: The Heart Center, Rigshospitalet, University of Copenhagen
name: Thomas Engstrom, MD, DMSci
role: PRINCIPAL_INVESTIGATOR
affiliation: The Heart Center, Rigshospitalet, University of Copenhagen
name: Henning Kelbaek, MD, DMSci
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mazhar J, Ekstrom K, Kozor R, Grieve SM, Nepper-Christensen L, Ahtarovski KA, Kelbaek H, Hofsten DE, Kober L, Vejlstrup N, Vernon ST, Engstrom T, Lonborg J, Figtree GA. Cardiovascular magnetic resonance characteristics and clinical outcomes of patients with ST-elevation myocardial infarction and no standard modifiable risk factors-A DANAMI-3 substudy. Front Cardiovasc Med. 2022 Aug 3;9:945815. doi: 10.3389/fcvm.2022.945815. eCollection 2022.
citation: Ekstrom K, Nielsen JVW, Nepper-Christensen L, Ahtarovski KA, Kyhl K, Goransson C, Bertelsen L, Ghotbi AA, Kelbaek H, Hofsten DE, Kober L, Schoos MM, Vejlstrup N, Lonborg J, Engstrom T. Ischemia From Nonculprit Stenoses Is Not Associated With Reduced Culprit Infarct Size in Patients with ST-Segment-Elevation Myocardial Infarction. Circ Cardiovasc Imaging. 2021 May;14(5):e012290. doi: 10.1161/CIRCIMAGING.120.012290. Epub 2021 May 5.
citation: Nepper-Christensen L, Hofsten DE, Helqvist S, Lassen JF, Tilsted HH, Holmvang L, Pedersen F, Joshi F, Sorensen R, Bang L, Botker HE, Terkelsen CJ, Maeng M, Jensen LO, Aaroe J, Kelbaek H, Kober L, Engstrom T, Lonborg J. Interaction of ischaemic postconditioning and thrombectomy in patients with ST-elevation myocardial infarction. Heart. 2020 Jan;106(1):24-32. doi: 10.1136/heartjnl-2019-314952. Epub 2019 Jul 17.
citation: Ekstrom K, Nepper-Christensen L, Ahtarovski KA, Kyhl K, Goransson C, Bertelsen L, Ghotbi AA, Kelbaek H, Helqvist S, Hofsten DE, Kober L, Schoos MM, Vejlstrup N, Lonborg J, Engstrom T. Impact of Multiple Myocardial Scars Detected by CMR in Patients Following STEMI. JACC Cardiovasc Imaging. 2019 Nov;12(11 Pt 1):2168-2178. doi: 10.1016/j.jcmg.2019.01.032. Epub 2019 Apr 17.
citation: Nepper-Christensen L, Lonborg J, Hofsten DE, Ahtarovski KA, Bang LE, Helqvist S, Kyhl K, Kober L, Kelbaek H, Vejlstrup N, Holmvang L, Engstrom T. Benefit From Reperfusion With Primary Percutaneous Coronary Intervention Beyond 12 Hours of Symptom Duration in Patients With ST-Segment-Elevation Myocardial Infarction. Circ Cardiovasc Interv. 2018 Sep;11(9):e006842. doi: 10.1161/CIRCINTERVENTIONS.118.006842.
citation: Falkentoft AC, Rorth R, Iversen K, Hofsten DE, Kelbaek H, Holmvang L, Frydland M, Schoos MM, Helqvist S, Axelsson A, Clemmensen P, Jorgensen E, Saunamaki K, Tilsted HH, Pedersen F, Torp-Pedersen C, Kofoed KF, Goetze JP, Engstrom T, Kober L. MR-proADM as a Prognostic Marker in Patients With ST-Segment-Elevation Myocardial Infarction-DANAMI-3 (a Danish Study of Optimal Acute Treatment of Patients With STEMI) Substudy. J Am Heart Assoc. 2018 May 18;7(11):e008123. doi: 10.1161/JAHA.117.008123.
citation: Lonborg J, Engstrom T, Ahtarovski KA, Nepper-Christensen L, Helqvist S, Vejlstrup N, Kyhl K, Schoos MM, Ghotbi A, Goransson C, Bertelsen L, Holmvang L, Pedersen F, Jorgensen E, Saunamaki K, Clemmensen P, De Backer O, Klovgaard L, Hofsten DE, Kober L, Kelbaek H; DANAMI-3 Investigators. Myocardial Damage in Patients With Deferred Stenting After STEMI: A DANAMI-3-DEFER Substudy. J Am Coll Cardiol. 2017 Jun 13;69(23):2794-2804. doi: 10.1016/j.jacc.2017.03.601.
citation: Topal DG, Lonborg J, Ahtarovski KA, Nepper-Christensen L, Helqvist S, Holmvang L, Pedersen F, Clemmensen P, Saunamaki K, Jorgensen E, Kyhl K, Ghotbi A, Schoos MM, Goransson C, Bertelsen L, Hofsten D, Kober L, Kelbaek H, Vejlstrup N, Engstrom T. Association Between Early Q Waves and Reperfusion Success in Patients With ST-Segment-Elevation Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention: A Cardiac Magnetic Resonance Imaging Study. Circ Cardiovasc Interv. 2017 Mar;10(3):e004467. doi: 10.1161/CIRCINTERVENTIONS.116.004467.
citation: Engstrom T, Kelbaek H, Helqvist S, Hofsten DE, Klovgaard L, Clemmensen P, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, Ravkilde J, Tilsted HH, Villadsen A, Aaroe J, Jensen SE, Raungaard B, Botker HE, Terkelsen CJ, Maeng M, Kaltoft A, Krusell LR, Jensen LO, Veien KT, Kofoed KF, Torp-Pedersen C, Kyhl K, Nepper-Christensen L, Treiman M, Vejlstrup N, Ahtarovski K, Lonborg J, Kober L; Third Danish Study of Optimal Acute Treatment of Patients With ST Elevation Myocardial Infarction-Ischemic Postconditioning (DANAMI-3-iPOST) Investigators. Effect of Ischemic Postconditioning During Primary Percutaneous Coronary Intervention for Patients With ST-Segment Elevation Myocardial Infarction: A Randomized Clinical Trial. JAMA Cardiol. 2017 May 1;2(5):490-497. doi: 10.1001/jamacardio.2017.0022.
citation: Nepper-Christensen L, Lonborg J, Ahtarovski KA, Hofsten DE, Kyhl K, Ghotbi AA, Schoos MM, Goransson C, Bertelsen L, Kober L, Helqvist S, Pedersen F, Saunamaki K, Jorgensen E, Kelbaek H, Holmvang L, Vejlstrup N, Engstrom T. Left Ventricular Hypertrophy Is Associated With Increased Infarct Size and Decreased Myocardial Salvage in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention. J Am Heart Assoc. 2017 Jan 9;6(1):e004823. doi: 10.1161/JAHA.116.004823.
citation: Kelbaek H, Hofsten DE, Kober L, Helqvist S, Klovgaard L, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, De Backer O, Bang LE, Kofoed KF, Lonborg J, Ahtarovski K, Vejlstrup N, Botker HE, Terkelsen CJ, Christiansen EH, Ravkilde J, Tilsted HH, Villadsen AB, Aaroe J, Jensen SE, Raungaard B, Jensen LO, Clemmensen P, Grande P, Madsen JK, Torp-Pedersen C, Engstrom T. Deferred versus conventional stent implantation in patients with ST-segment elevation myocardial infarction (DANAMI 3-DEFER): an open-label, randomised controlled trial. Lancet. 2016 May 28;387(10034):2199-206. doi: 10.1016/S0140-6736(16)30072-1. Epub 2016 Apr 3.
citation: Hofsten DE, Kelbaek H, Helqvist S, Klovgaard L, Holmvang L, Clemmensen P, Torp-Pedersen C, Tilsted HH, Botker HE, Jensen LO, Kober L, Engstrom T; DANAMI 3 Investigators. The Third DANish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarction: Ischemic postconditioning or deferred stent implantation versus conventional primary angioplasty and complete revascularization versus treatment of culprit lesion only: Rationale and design of the DANAMI 3 trial program. Am Heart J. 2015 May;169(5):613-21. doi: 10.1016/j.ahj.2015.02.004. Epub 2015 Feb 14.