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ST-elevation Myocardial Infarction (STEMI)POSTDILSTEMINCT02788396

The Impact of Post Stenting Balloon Dilatation on Coronary Microcirculation in STEMI Patients Undergoing PPCI

An observational study of ST-elevation Myocardial Infarction (STEMI), run by Mid and South Essex NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to assess the impact of NC balloon post-dilatation on coronary microcirculation in patients with ST segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). Read more about this study

Who is it for?
Ages 18 years and older
How many people
30 participants
Where
1 siteUnited Kingdom
Study dates
1 May 2016to 31 May 2018
Phase
Observational
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

Study population: STEMI patients undergoing PPCI

Who may be able to join

  • >18 years of age
  • Acute symptoms onset with duration > 20 minutes
  • ST-segment elevation ≥ 0.1 mV in ≥ 2 contiguous leads, signs of a true posterior infarction or documented newly developed left bundle branch block
  • Infarct related artery with a diameter above 2.5 mm
  • Operator's intention to proceed to stent deployment (i.e. not refer for CABG or defer PCI)

Who cannot join

  • < 18 year of age
  • Symptoms duration > 12 hours
  • Unable to give informed consent
  • Previous bypass graft surgery
  • Previous myocardial infarction
  • Pregnancy
Show all 13Show fewer
  • Known severe chronic kidney disease (creatinine clearance ≤30 mL/min), unless the patient is on dialysis
  • Unable to receive antiplatelets or anticoagulation (i.e. coagulation disorders, bleeding etc.)
  • Haemodynamic instability
  • Severe LMS disease
  • Culprit vessel diameter < 2.5 mm
  • Contraindications to adenosine
  • Any study lesion characteristic resulting in the expected inability to deliver OCT catheter to the lesion pre and post PD (e.g. moderate or severe vessel calcification or tortuosity)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • The Essex Cardiothoracic Centre

    Basildon, Essex, SS16 5NL

Other trials in United Kingdom

About this study

Official title: The Impact of Post Stenting Balloon Dilatation on Coronary Microcirculation in ST Segment Elevation Myocardial Infarction (STEMI) Patients Undergoing Primary Percutaneous Coronary Intervention (PPCI)

This study aims to assess the impact of NC balloon post-dilatation on coronary microcirculation in patients with ST segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI).

Read the detailed description

Suboptimal stent deployment can lead to future stent failure. Thus, optimising stent deployment with non-compliant balloons (NC balloon) post dilatation (PD) at high pressures is an established strategy. In the context of ST segment elevation myocardial infarction (STEMI), PD has been correlated anecdotally with the no reflow phenomenon.

This study aims to determine the impact of stent post-dilation (PD) with NC balloons at high pressures on coronary microcirculation during PPCI by measuring the index of microcirculatory resistance (IMR) pre and post stent post-dilatation. Pre and post PD, an optical coherence tomography (OCT) study will be performed to assess stent deployment and identify parameters that predict the changes in IMR.

Keywords
STEMI, PPCI, post-dilatation, coronary microcirculation
Medical subject headings
ST Elevation Myocardial Infarction

What is being measured

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

  1. Delta index of microcirculatory resistance (dIMR)

    Delta index of microcirculatory resistance (dIMR) [dΙΜΡ = IMR post post-dilation (post IMR) - IMR pre post-dilation (pre IMR)]

    Measured: index procedure

Secondary outcomes (5)

  1. Minimum stent area (MSA)

    Pre and post dilatation minimum stent area

    Measured: index procedure

  2. Stent expansion

    Pre and post dilatation stent expansion; defined as the minimum stent area divided by the average of proximal and distal reference lumen areas x 100

    Measured: index procedure

  3. Stent mal-apposition

    Stent mal-apposition pre and post dilatation; defined as a distance between the strut's luminal edge and luminal vessel wall of greater >200 μm for a length >600 μm (appreciable in >3 contiguous frames at a pull-back speed of 20 mm/sec

    Measured: index procedure

  4. Intra-stent plaque protrusion and thrombus

    Pre and post dilatation intra-stent plaque protrusion and thrombus; defined as a mass attached to the luminal surface or floating within the lumen at least 200 μm beyond the luminal edge of a strut

    Measured: index procedure

  5. Stent edge dissections

    Edge dissections pre and post dilatation, further defined as major and minor [major dissections defined as the ones with a dissection flap width greater or equal to 200 μm)

    Measured: index procedure

Timeline

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

  1. First posted2 Jun 2016 (estimated)
  2. Study start1 May 2016
  3. Primary completion31 May 2018
  4. Study completion31 May 2018

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02788396
Sponsor's protocol ID
B853
Acronym
POSTDILSTEMI
Status last verified
Aug 2021
First submitted
27 May 2016
Last updated
1 Sep 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Karamasis GV, Kalogeropoulos AS, Gamma RA, Clesham GJ, Marco V, Tang KH, Jagathesan R, Sayer JW, Robinson NM, Kabir A, Aggarwal RK, Kelly PA, Prati F, Keeble TR, Davies JR. Effects of stent postdilatation during primary PCI for STEMI: Insights from coronary physiology and optical coherence tomography. Catheter Cardiovasc Interv. 2021 Jun 1;97(7):1309-1317. doi: 10.1002/ccd.28932. Epub 2020 Apr 23.

    PubMed 32329200

Questions about this trial

What is this clinical trial studying?

An observational study of ST-elevation Myocardial Infarction (STEMI), run by Mid and South Essex NHS Foundation Trust at 1 site in United Kingdom.

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 5 inclusion and 13 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: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Delta index of microcirculatory resistance (dIMR) (time frame: index procedure). 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 NCT02788396, which also lists 1 linked publication.

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 1 Sep 2021.

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