Barts-MINOCA Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorQueen Mary University of London
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients <16 years will not be included in this study.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Observation only
Other interventionObservation only
Treatment groups
3,000 Participants
are divided into 1 treatment groupGroup A: Troponin rise/ diagnosis of MINOCA1 intervention
Trial outcomes
Primary outcomes
1
Mortality
Assessment of mortality
Time frame
30 days2
Mortality
Assessment of mortality
Time frame
1 year3
Formal diagnosis made of the cause of troponin rise
Diagnosis
Time frame
Baseline4
Timing of diagnosis made of the cause of troponin rise
Time to first diagnosis
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov