Barts-MINOCA Registry

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04440761
• Other study ID #: REDA: 130386
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: August 2023
• Source: Queen Mary University of London
• Contact: Daniel Jones, MBBS, PhD
• Phone: 020 7377 7000
• Email: dan.jones8[@]nhs.net
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Microvascular Disease
• Gender
• Infarction
• Microvascular Angina
• Myocardial Infarction

Intervention

Other:
• Observation only
Observation only

Locations

Country	Name	City	State
United Kingdom	Barts Health NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

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