NCT01552564

Brief Summary

This study investigates the association between the microvascular resistance at the time of primary percutaneous intervention, with microvascular obstruction on CMR and blood markers of myocardial damage.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Last Updated

October 28, 2014

Status Verified

October 1, 2014

Enrollment Period

1.8 years

First QC Date

March 9, 2012

Last Update Submit

October 27, 2014

Conditions

STEMI

Outcome Measures

Primary Outcomes (1)

  • Microvascular obstruction

    Microvascular obstruction as a percentage of the left ventricle at 2-4 days.

    DAy 2-4

Study Arms (1)

STEMI patients

Consecutive patients presenting through the PPCI service

Procedure: Index of microvascular resistanceOther: Cardiac magnetic resonanceOther: Blood markers

Interventions

Index of microvascular resistancePROCEDURE
STEMI patients
Cardiac magnetic resonanceOTHER
STEMI patients
Blood markersOTHER
STEMI patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

STEMI attending Bristol Heart Institute via the primary PCI service

You may qualify if:

  • \>18 years old
  • Cardiac symptoms of \> 20 mins chest pain or equivalent.
  • ECG criteria consistent with STEMI (STEMI)
  • Proceeding with percutaneous angioplasty
  • Assent/ consent to the study

You may not qualify if:

  • Known allergy to adenosine or gadolinium
  • Chronic atrial fibrillation
  • Renal impairment with eGFR \<30
  • Contraindication to angiography
  • Contraindication to CMR (implanted pacemaker/ defibrillator, ferromagnetic metal implant/ injury, claustrophobia, obesity/ too large for CMR scanner)
  • Cardiogenic shock
  • Patients with special communication needs or altered consciousness.
  • Patients who do not give assent/consent to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bristol Heart Institute

Bristol, BS2 8HW, United Kingdom

Location

Related Publications (1)

  • McAlindon E, Pufulete M, Harris J, Lawton C, Johnson T, Strange J, Baumbach A, Bucciarelli-Ducci C. Microvascular dysfunction determines infarct characteristics in patients with reperfused ST-segment elevation myocardial infarction: The MICROcirculation in Acute Myocardial Infarction (MICRO-AMI) study. PLoS One. 2018 Nov 13;13(11):e0203750. doi: 10.1371/journal.pone.0203750. eCollection 2018.

    PMID: 30422990DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Fellow

Study Record Dates

First Submitted

March 9, 2012

First Posted

March 13, 2012

Study Start

March 1, 2012

Primary Completion

January 1, 2014

Last Updated

October 28, 2014

Record last verified: 2014-10

Locations

GB(1)