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ST-elevation Myocardial InfarctionPRIMULTINCT01960933

Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization

A study testing Percutaneous coronary intervention and FFR in people with ST-elevation Myocardial Infarction and Multi Vessel Disease, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In patients with ST-elevation myocardial infarction (STEMI) the primary treatment is acute angioplasty of the acute occlusion (culprit lesion). In STEMI patients with multi vessel disease (MVD) no evidence based treatment of the non-culprit lesions exists. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Percutaneous coronary intervention and FFR
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
650 participants
Where
2 sitesDenmark
Study dates
May 2011to Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years.
  • Acute onset of chest pain of < 12 hours' duration.
  • ST-segment elevation ≥ 0.1 millivolt 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.
  • MVD (non-culprit vessels with angiographic stenosis >50%)
  • Successful primary PCI

Who cannot join

  • Pregnancy.
  • Known intolerance of acetylsalicylic acid, clopidogrel, heparin or contrast.
  • Inability to understand information or to provide informed consent.
  • Haemorrhagic diathesis or known coagulopathy.
  • Stent thrombosis
  • Significant left main stem stenosis
  • Cardiogenic shock at admittance

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Aalborg University Hospital

    Aalborg, 9100

  • Rigshospitalet, University of Copenhagen

    Copenhagen, 2100

Other trials in Denmark

About this study

Official title: Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization (DANAMI-3-PRIMULTI) A Randomised Comparison of the Clinical Outcome After Complete Revascularisation Versus Treatment of the Infarct-related Artery Only During Primary Percutaneous Coronary Intervention

In patients with ST-elevation myocardial infarction (STEMI) the primary treatment is acute angioplasty of the acute occlusion (culprit lesion). In STEMI patients with multi vessel disease (MVD) no evidence based treatment of the non-culprit lesions exists. We aim to provide evidence as to whether full revascularization or revascularization of the culprit lesion only provides the best prognosis for the patient.

Read the detailed description

STEMI patients with MVD (30% of total STEMI population) are - following successful primary angioplasty - randomized to either no additional percutaneous coronary intervention (PCI) of other lesions or full revascularisation guided by fractional flow reserve (FFR).

Eligible coronary arteries must be >2.0 mm in diameter and at the discretion of the operator suitable for PCI. Only arteries with angiographically stenoses > 50% can be randomized. All randomized lesions with diameter stenosis > 50% and < 90% are evaluated by FFR and a FFR value < 0.80 is considered significant and treated. Stenoses >90% are treated without prior FFR.

Full revascularization is a priori obtained by means of PCI. If, however, PCI is considered inferior to coronary artery bypass grafting the latter option can be chosen.

Being tested
Percutaneous coronary intervention, FFR
Keywords
STEMI, MVD, Full revascularization, Culprit lesion revascularization only, Primary PCI
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous coronary interventionProcedure or surgery

  • FFRProcedure or surgery

Study groups in NCT01960933
Study groupRoleWhat they receive
Culprit lesion revascularizationActive comparatorOnly the culprit lesion is treated whereas other study lesions are left un-treated.
Receives: Procedure: Percutaneous coronary intervention
Full revascularizationActive comparatorCulprit lesion is treated initially and all other lesions with diameter stenosis angiographically >50% and FFR <0.80 are treated in a separate procedure within the index hospitalization. Stenoses > 90% are treated without prior FFR.
Receives: Procedure: Percutaneous coronary intervention; Procedure: FFR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All cause death, myocardial infarction or revascularization

    Composite of all cause mortality, myocardial infarction, or ischemia (either subjective or objective) driven revascularization of non-culprit coronary lesions eligible for and randomized to either of the two treatment arms at the time of the index procedure

    Measured: 1 year

Secondary outcomes (6)

  1. Cardiac death or myocardial infarction

    Measured: 1 year

  2. Hospitalization for acute coronary syndrome or acute heart failure

    Measured: 1 year

  3. Angina status and quality of life

    Measured: 1 year

  4. Infarct size in relation to area at risk as determined by MRI

    Measured: 3 months

  5. Cardiac death, myocardial infarction, repeat revascularisation or occurrence of definite stent thrombosis (according to ARC definition) of non culprit lesions

    Measured: 2 years

  6. Wall motion index (WMI) determined by echocardiography

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2013 (estimated)
  2. Study startMay 2011
  3. Primary completionFeb 2015
  4. Study completionFeb 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
650 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01960933
Sponsor's protocol ID
DANAMI-3-PRIMULTI
Acronym
PRIMULTI
Status last verified
Nov 2023
First submitted
9 Oct 2013
Last updated
28 Nov 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • Elezi B, Marquard JM, Kelbaek H, Nepper-Christensen L, Ahtarovski K, Kyhl K, Goransson C, Islam U, Kober L, Hofsten D, Pedersen F, Vejlstrup NG, Holmvang L, Engstrom T, Lonborg JT. Ten-year prognostic impact of cardiac magnetic resonance endpoints in patients with ST-segment elevation myocardial infarction. Eur Heart J Cardiovasc Imaging. 2026 Mar 27;27(4):652-661. doi: 10.1093/ehjci/jeag001.

    PubMed 41493904

  • Ozbek BT, Islam U, Marquard JM, Kelbaek H, Kunkel JB, Holmvang L, Tilsted HH, Pedersen F, Koeber L, Hofsten D, Eftekhari A, Raungaard B, Bottker HE, Terkelsen CJ, Christiansen E, Khalek IMA, Jensen LO, Engstrom T, Lonborg JT. Ten-year target lesion failure in patients treated with primary PCI: results from DANAMI-3. Open Heart. 2025 Nov 13;12(2):e003588. doi: 10.1136/openhrt-2025-003588.

    PubMed 41238348

  • Marquard JM, Beske RP, Kelbaek H, Holmvang L, Pedersen F, Clemmensen P, De Backer O, Raungaard B, Eftekhari A, Islam U, Kober L, Tilsted HH, Glinge C, Jabbari R, Scheike T, Hofsten DE, Lonborg JT, Engstrom T. 10-Year Outcome of Complete or Infarct Artery-Only Revascularization in STEMI With Multivessel Disease: The DANAMI-3-PRIMULTI Study. J Am Coll Cardiol. 2025 Jul 15;86(2):119-129. doi: 10.1016/j.jacc.2025.05.013. Epub 2025 May 20.

    PubMed 40392668

  • 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.

    PubMed 35990971

  • 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.

    PubMed 33951923

  • 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.

    PubMed 31005537

  • Wang LJ, Han S, Zhang XH, Jin YZ. Fractional flow reserve-guided complete revascularization versus culprit-only revascularization in acute ST-segment elevation myocardial infarction and multi-vessel disease patients: a meta-analysis and systematic review. BMC Cardiovasc Disord. 2019 Mar 1;19(1):49. doi: 10.1186/s12872-019-1022-6.

    PubMed 30823897

  • 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.

    PubMed 30354595

  • Kobayashi Y, Lonborg J, Jong A, Nishi T, De Bruyne B, Hofsten DE, Kelbaek H, Layland J, Nam CW, Pijls NHJ, Tonino PAL, Warnoe J, Oldroyd KG, Berry C, Engstrom T, Fearon WF; DANAMI-3-PRIMULTI, FAME, and FAMOUS-NSTEMI Study Investigators. Prognostic Value of the Residual SYNTAX Score After Functionally Complete Revascularization in ACS. J Am Coll Cardiol. 2018 Sep 18;72(12):1321-1329. doi: 10.1016/j.jacc.2018.06.069.

    PubMed 30213322

  • 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.

    PubMed 29776961

  • Lonborg J, Engstrom T, Kelbaek H, Helqvist S, Klovgaard L, Holmvang L, Pedersen F, Jorgensen E, Saunamaki K, Clemmensen P, De Backer O, Ravkilde J, Tilsted HH, Villadsen AB, Aaroe J, Jensen SE, Raungaard B, Kober L, Hofsten DE; DANAMI 3-PRIMULTI Investigators. Fractional Flow Reserve-Guided Complete Revascularization Improves the Prognosis in Patients With ST-Segment-Elevation Myocardial Infarction and Severe Nonculprit Disease: A DANAMI 3-PRIMULTI Substudy (Primary PCI in Patients With ST-Elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization). Circ Cardiovasc Interv. 2017 Apr;10(4):e004460. doi: 10.1161/CIRCINTERVENTIONS.116.004460.

    PubMed 28404623

  • Engstrom T, Kelbaek H, Helqvist S, Hofsten DE, Klovgaard L, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, Clemmensen P, De Backer O, Ravkilde J, Tilsted HH, Villadsen AB, Aaroe J, Jensen SE, Raungaard B, Kober L; DANAMI-3-PRIMULTI Investigators. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3-PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015 Aug 15;386(9994):665-71. doi: 10.1016/s0140-6736(15)60648-1.

    PubMed 26347918

  • 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.

    PubMed 25965708

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous coronary intervention and FFR in people with ST-elevation Myocardial Infarction and Multi Vessel Disease, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All cause death, myocardial infarction or revascularization (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01960933, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.

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