Resistance STEMI Study

July 14, 2020 updated by: Nico Pijls, Catharina Ziekenhuis Eindhoven

Recovery of Microvascular Myocardial Resistance After ST Elevation Myocardial Infarction and Its Relation to Outcome. A Prospective Exploratory Study

In acute myocardial infarction, early restoration of blood flow to the jeopardized myocardium is of paramount importance to limit infarct size and to improve long term outcome. Primary percutaneous coronary intervention (PPCI) is the treatment of choice in these patients. Despite achievement of adequate epicardial coronary artery reperfusion in many patients, transient or persistent myocardial microvascular dysfunction is often present, also referred to as the no-reflow phenomenon. This microvascular dysfunction and the time course during which it recovers, is most likely also related to long term outcome.

If microvascular reperfusion is still limited immediately after myocardial infarction but recovers quickly in the days thereafter, this might be beneficial for long term prognosis.

Several treatments have been suggested to limit microvascular injury and to improve microvascular reperfusion in the acute phase of myocardial infarction (such as intra-aortic balloon pumping, glycoprotein IIB/IIIA inhibitors, adenosine, verapamil, nitroglycerine, cyclosporine, or gap-junction-inhibitors), but it has been difficult to assess the effect of such treatment due to the simple fact that no methodology has been available for quantitative assessment of the microcirculation of the heart.

Assessment of microvascular perfusion and function has been very difficult so far and has been hampered by a number of methodological and technical shortcomings. Measurement of absolute blood flow in the infarcted area and true quantitative calculation of absolute resistance in acute myocardial infarction, has been introduced in the last years using a technique with thermodilution and continuous infusion of small amounts of saline. This technique offers the possibility to study the course of microvascular (dys)function after acute myocardial infarction with potentially important implications for treatment at follow-up. Technical performance of such measurements was difficult so far because of a complex instrumentation and the necessity of additional administration of intravenous adenosine. In the last 2 years, this technique has been largely simplified by the introduction of a new multipurpose monorail infusion catheter (RayFlow ®, Hexacath, Paris) and the observation that saline infusion of 15-20 ml/min in itself already ensures maximum coronary hyperemia. Finally, easy to handle software has been developed for online interpretation of such measurements. Consequently, measurement of absolute blood flow and myocardial resistance has become easy to perform now and the complete measurements only take a few minutes in addition to a regular PPCI or Fractional Flow Reserve (FFR) measurement. The measurements are absolutely safe, reproducible, only a small amount of saline (100 ml at room temperature) is needed, no additional medication is necessary, the patient doesn't experience any discomfort of the measurement and the measurements can be repeated multiple times within minutes.

Therefore, a window is opened for further examination and quantitative assessment of the microcirculation of the heart. The purpose of the present study is to evaluate changes in myocardial resistance over time in ST-Elevation Myocardial Infarction (STEMI) patients, both in the early stage and the subacute phase. Furthermore, the course of such changes and recovery of the microcirculation will be correlated to long-term outcome as assessed by Magnetic Resonance Imaging (MRI) measurements and final infarct size. It is hypothesized that patients can be divided into 3 groups:

A. Patients with an (almost) normal resistance and flow immediately after PPCI B. Patients with still elevated resistance and decreased flow immediately after PPCI, but (partial) recovery in the next days C. Patients with elevated resistance and decreased flow immediately after PPCI which do not recover at all.

The investigators would like to evaluate changes in microvascular resistance of the infarcted area in the first hour after ST-elevation myocardial infarction and during the recovery period (<5 days). Classify patients according to recovery of microvascular resistance and relate the (recovery of) microvascular resistance to outcome and preservation of left ventricular function (with MRI, echo and clinical follow-up at 1 year).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Brabant
      • Eindhoven, Brabant, Netherlands, 5623EJ
        • Catharina Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18 and 75 years
  • Presentation within 12 hours after the onset of complaints
  • Acute ST-elevation myocardial infarction with a total ST segment deviation ≥5 mm
  • Able to give and understand informed consent
  • Culprit lesion in a proximal or mid-segment of one of the major coronary arteries (diameter ≥2,5 mm), which is stented successfully
  • Stable condition after stenting
  • One or more additional lesions in one or more different coronary arteries, mandating FFR measurement +/- PPCI during the subacute phase

Exclusion Criteria:

  • Age < 18 years or > 75 years
  • Cardiogenic shock or pre-shock, determined by the clinician
  • Patients with previous myocardial infarction in the culprit artery or with previous bypass surgery
  • Very tortuous or calcified coronary arteries
  • Long or complex PPCI
  • Severe concomitant disease or conditions with a life expectancy of less than 1 year
  • Inability to understand and give informed consent
  • Known myocardial diseases such as severe left ventricular hypertrophy or cardiomyopathy
  • Pregnancy
  • Severe conduction disturbances necessitating implantation of a temporary pacemaker
  • Contraindications for MRI (claustrophobia, ferromagnetic metal fragments in the body)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Study arm
The study arm will undergo absolute flow and resistance measurements immediately after PPCI of the culprit artery
Diagnostic test: Absolute flow and resistance measurement
Absolute flow and resistance measurements immediately after PPCI of the culprit vessel (in a STEMI setting) and repeated absolute flow and resistance measurements after 3-7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary endpoint - changes in microvascular resistance
Time Frame: From date of randomization until the date of the second measurements (all within the first week after the index event).
To evaluate changes in microvascular resistance of the infarcted area in the first hour after ST-elevation myocardial infarction and during the recovery period (<5 days) measured invasively with the absolute flow and resistance measurement.
From date of randomization until the date of the second measurements (all within the first week after the index event).
Co-primary endpoint - risk stratification
Time Frame: From date of randomization until the date of clinical follow-up at 1 year.
The co-primary endpoint is to see whether the microvascular resistance can classify the patients into groups and identify those with a higher risk of reduced left ventricular function and more adverse events in the end.
From date of randomization until the date of clinical follow-up at 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary endpoint - left ventricular function
Time Frame: From date of randomization until the date of clinical follow-up at 1 year.
To relate (recovery of) microvascular resistance to the preservation of left ventricular function (assessed by MRI and echocardiography).
From date of randomization until the date of clinical follow-up at 1 year.
Secondary outcome- Major adverse events
Time Frame: From date of randomization until the date of clinical follow-up at 1 year.
To relate (recovery of) microvascular resistance to the outcome (adverse events / mortality) during to complete clinical follow up of the patient at 3 months and 1 year
From date of randomization until the date of clinical follow-up at 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catharina Ziekenhuis Eindhoven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2018

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

February 2, 2018

First Submitted That Met QC Criteria

February 19, 2018

First Posted (Actual)

February 20, 2018

Study Record Updates

Last Update Posted (Actual)

July 16, 2020

Last Update Submitted That Met QC Criteria

July 14, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Resistance STEMI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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