Barts-MINOCA Registry

Barts Myocardial Infarction With Non-Obstructed Coronary Arteries (MINOCA) Registry

The last 15 years the introduction of primary angioplasty has radically improved outcomes for acute myocardial infarction (AMI). However, the system wide availability of prompt investigation has revealed an important group of patients where progress has stalled, the diagnosis is unclear and therapeutic approaches are uncertain. Myocardial infarction with non-obstructive coronary arteries (MINOCA) is found in 1 - 13% of all patients with a clinical diagnosis of AMI.

These patients present a therapeutic predicament since coronary revascularization is not appropriate. Guidelines do not exist for their management - yet the condition is not benign - the 12-month prognosis, although better than obstructive coronary artery disease patients is still guarded with recent data suggesting many questions remain unanswered.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction; Coronary Microvascular Disease; Gender
• Intervention / Treatment: Other: Observation only

Detailed Description

This study utilises a prospectively collected clinical database. All patients referred to the Interventional Cardiology team are included onto this database. No patients will be contacted solely for research purposes. Patients will not have any investigations/procedures performed for research purposes. All data will only be available for access by named members of the Interventional Cardiology team. Data will be anonymised by the clinical care team and passed onto the research team before it is used and no patient identifiable information will be used in the analysis of the study or the publications of its results.

The database started in April 2015 and has collected data on all patients so far and will continue to do so for the duration of clinical work by the Interventional Cardiology team. As a result this study will continue indefinitely.

This study will include all patients admitted to or reviewed in clinic at Barts Health NHS Trust with either a diagnosis of MINOCA or who do not have a clear cause of a troponin rise. These patients range from young adults to the elderly and will include any patient ≥16 years of age. Patients who are followed up with and without any intervention (i.e. both medically managed patients as well as patients undergoing intervention) are equally as important and therefore the investigators shall include both groups of patients.

Patients will be included from referrals made by other clinicians either as in or outpatients. All these patients have their clinical data captured on a database or hospital based clinical programme.

This study aims to assess, in a real-world setting, the safety, efficacy and feasibility of further investigations in patients diagnosed with MINOCA among all patients with coronary artery disease.

The study will test various hypothesis including but not limited to:

1. The efficacy of diagnosis rates of CMR in patients diagnosed with MINOCA
2. Outcomes in patients diagnosed with MINOCA treated medically
3. Long-term outcome of patients diagnosed with MINOCA

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Daniel Jones, MBBS, PhD; Phone Number: 020 7377 7000; Email: dan.jones8@nhs.net
• Study Contact Backup: Name: Krishnaraj Rathod, MBBS, PhD; Phone Number: 020 7377 7000; Email: krishnaraj.rathod1@nhs.net

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • Barts Health NHS Trust
    • Contact: Dr Anne-Marie Beirne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will include all patients admitted to or reviewed in clinic at Barts Health NHS Trust with either a diagnosis of MINOCA or who do not have a clear cause of a troponin rise. These patients range from young adults to the elderly and will include any patient ≥16 years of age. Patients who are followed up with and without any intervention (i.e. both medically managed patients as well as patients undergoing intervention) are equally as important and therefore we shall include both groups of patients.

Patients will be included from referrals made by other clinicians either as in or outpatients. All these patients have their clinical data captured on a database or hospital based clinical programme.

Description

Inclusion Criteria:

• Both male and female patients ≥16 years of age will be included
• All patients will have a diagnosis MINOCA. Any patient who does not have a clear cause of troponin rise

Exclusion Criteria:

• Patients <16 years will not be included in this study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Troponin rise/ diagnosis of MINOCA; This study aims to assess, in a real-world setting, the safety, efficacy and feasibility of further investigations in patients diagnosed with MINOCA among all patients with coronary artery disease.	Other: Observation only; Observation only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Assessment of mortality	30 days
Mortality	Assessment of mortality	1 year
Formal diagnosis made of the cause of troponin rise	Diagnosis	Baseline
Timing of diagnosis made of the cause of troponin rise	Time to first diagnosis	Baseline
Questionnaire to assess change in symptoms at 2 months post-initial review in clinic/ward	Change in symptoms assessed by Questionnaire	2 months

Collaborators and Investigators

• Sponsor: Queen Mary University of London
• Investigators: Principal Investigator: Daniel Jones, MBBS, PhD, Queen Mary University of London

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 22, 2020

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Myocardial Infarction; Infarction; Microvascular Angina
• Other Study ID Numbers: REDA: 130386

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No