NCT04440761

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
Jul 2020Sep 2026

First Submitted

Initial submission to the registry

June 15, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2026

Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

6.2 years

First QC Date

June 15, 2020

Last Update Submit

November 17, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (1)

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

Interventions

Observation only

Troponin rise/ diagnosis of MINOCA

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barts Health NHS Trust

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Myocardial InfarctionCoitusMicrovascular Angina

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisSexual BehaviorBehaviorAngina Pectoris

Study Officials

  • Daniel Jones, MBBS, PhD

    Queen Mary University of London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Jones, MBBS, PhD

CONTACT

Krishnaraj Rathod, MBBS, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2020

First Posted

June 22, 2020

Study Start

July 1, 2020

Primary Completion (Estimated)

September 16, 2026

Study Completion (Estimated)

September 16, 2026

Last Updated

November 18, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations