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Resistance STEMI Study

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ClinicalTrials.gov Identifier: NCT03439150
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Nico Pijls, Catharina Ziekenhuis Eindhoven

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
STEMI Acute Myocardial Infarction Diagnostic Test: Absolute flow and resistance measurement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Recovery of Microvascular Myocardial Resistance After ST Elevation Myocardial Infarction and Its Relation to Outcome. A Prospective Exploratory Study
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439150


Contacts
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Contact: Nico Pijls, MD, PhD 0031402394000 nico.pijls@catharinaziekenhuis.nl
Contact: Danielle Keulards, MD danielle.keulards@catharinaziekenhuis.nl

Locations
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Netherlands
Catharina Hospital Recruiting
Eindhoven, Brabant, Netherlands, 5623EJ
Contact: Nico Pijls, MD, PhD    0402397000    nico.pijls@catharinaziekenhuis.nl   
Contact: Danielle Keulards, MD    0402397000    danielle.keulards@catharinaziekenhuis.nl   
Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
Investigators
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Principal Investigator: Nico Pijls, MD, PhD Catharina Ziekenhuis Eindhoven
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Responsible Party: Nico Pijls, N.H.J Pijls, MD, PhD, Professor of Cardiology, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier: NCT03439150    
Other Study ID Numbers: Resistance STEMI
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Nico Pijls, Catharina Ziekenhuis Eindhoven:
Absolute flow measurement
Microvascular resistance
Left ventricular function
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases