Coronary Microcirculation Assessment After Primary Angioplasty in Myocardial Infarction

NCT04542889 | Terminated

• 2 other identifiers: APHP1908312019-A02413-54
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

In the management of acute myocardial infarction treated with primary angioplasty, despite effective epicardial clearance obtained in 95% of cases, microvascular obstruction (MVO) in the damaged territory concerns 50% of patients. The Index of Microvascular Resistance (IMR) allows early assessment of the microcirculatory state during the angioplasty procedure. A value of IMR\>40 indicates MVO and is correlated with morbi-mortality. A new method for immediate evaluation of MVO using thermodilution with a new Rayflow® microcatheter has been described: it no longer allows the estimation but the measurements of absolute coronary resistance and coronary flow. We hypothesize that these measurements allows a better evaluation of the microcirculatory state after primary angioplasty, comparing to IMR. The main objective is to study the diagnostic performance of Rayflow® to predict MVO - no reflow (NR) - in ST-Elevation Myocardial Infarction (STEMI) patients in order to determine an absolute coronary resistance threshold by thermodilution for early diagnosis of MVO. The main secondary objectives will be to compare the different microcirculatory assessment parameters with each other, not indexed and indexed to the myocardial mass at risk (coronary resistance, IMR, CFR, Resistance Reserve Ratio) and to establish a link between high resistance or IMR and the occurrence of rhythm disorders at D1, D2 and D3.

Conditions

STEMI - ST Elevation Myocardial Infarction

Keywords

Coronary physiology; Coronary microvascular circulation; STEMI; Microvascular Obstruction; No Reflow; Rayflow®; Absolute coronary resistance; IMR

Outcome Measures

Primary Outcomes (2)

• Absolute coronary resistance

  Threshold value correlated with microvascular obstruction on magnetic resonance imaging (MRI)

  Immediately after angioplasty

• Microvascular obstruction on MRI

  Establishment of a correlation between absolute coronary resistance and microvascular obstruction on MRI

  Day 7

Secondary Outcomes (6)

• Index of microvascular resistance

  Immediately after angioplasty

• Mean value of absolute coronary resistances corresponding to an IMR > 40

  Immediately after angioplasty

• Microvascular obstruction in patients with IMR > 40

  Day 7

• Absolute coronary resistance indexed to the myocardial mass

  Immediately after angioplasty

• IMR indexed to the myocardial mass

  Immediately after angioplasty

Study Arms (1)

Absolute coronary resistances and IMR after angioplasty

EXPERIMENTAL

Patients with STEMI by acute occlusion of a large caliber coronary artery that had been admitted to hospital less than 12 hours and revascularized by primary angioplasty with good final result.

Diagnostic Test: Absolute coronary flow and resistance measurements; Diagnostic Test: IMR measurement

Interventions

Absolute coronary flow and resistance measurements DIAGNOSTIC_TEST

Thermodilution-based measurements of absolute coronary resistances using the FFR pressure guide (PressureWire® Certus® from St Jude Medical Abbott) and the Rayflow® microcatheter (Hexacath, Paris, France).

Absolute coronary resistances and IMR after angioplasty

IMR measurement DIAGNOSTIC_TEST

IMR measurement by thermodilution using the St Jude pressure guide.

Absolute coronary resistances and IMR after angioplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute ST + coronary syndrome seen within 12 hours after the initial pain: ST offset in 2 contiguous leads ≥ 1mm or ≥ 2mm in precordial or inaugural left branch block, permanent or transient with chest pain \> 20 min
• Patient with an indication for emergency coronary angiography with angioplasty
• Acute occlusion of a large caliber artery corresponding to an APPROACH score ≥21: proximal or mean anterior interventricular artery, proximal circumflex artery or proximal right coronary artery
• Final Thrombolysis In Myocardial Infarction (TIMI) of 2 or 3 at the end of the angioplasty procedure regardless of the initial TIMI score
• Free and informed written consent to participate in the study

You may not qualify if:

• Technical impossibility of performing IMR or Rayflow® measurements (tortuous or calcified artery)
• Persistent high-grade atrioventricular block after primary angioplasty
• Cardiomyopathy or severe valvulopathy which can induce microcirculatory abnormalities (congenital heart diseases, dilated cardiomyopathy, cardiac amyloidosis, hypertrophic heart disease, mitral regurgitation, aortic regurgitation, tricuspid regurgitation or pulmonary regurgitation grade 3 or 4, tight aortic stenosis or pulmonary stenosis with average gradient \> 40 mmHg or vmax \> 4m/sec , tight mitral stenosis or tricuspid stenosis with average gradient \> 10mmHg)
• Contraindication to performing cardiac MRI: wearing a pacemaker, intracerebral clip, intraocular foreign body, neurostimulator, severe renal failure with glomerular filtration rate \< 30 mL/min, body weight \> 150 kg
• Age \< 18 years
• Pregnant or breastfeeding woman
• Patient not affiliated to a social security scheme
• Patient under guardianship or curatorship

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

APHP, Lariboisière Hospital, Cardiology Department

Paris, 75475, France

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Georgios SIDERIS, MD

  APHP, Lariboisière Hospital, Cardiology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: September 9, 2020
• Study Start: September 7, 2020
• Primary Completion: June 26, 2021
• Study Completion: June 26, 2021
• Last Updated: May 2, 2024

Record last verified: 2024-04

Locations

FR (1)