Stockholm Myocardial Infarction With Normal Coronaries (SMINC)-2 Study on Diagnosis Made by Cardiac MRI

Myocardial Infarction Clinical Trial

— SMINC-2  

Official title:

Stockholm Myocardial Infarction With Normal Coronaries (SMINC)-2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02318498
• Other study ID #: 2
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: April 2019

Study information

• Verified date: September 2019
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Myocardial infarction with angiographically normal coronary arteries (MINCA) is common (7-8 % of all myocardial infarctions). There are several different causes behind MINCA where "true infarction" due to thromboembolism, myocarditis or Takotsubo stress cardiomyopathy are the main findings. The underlying diagnosis is often made by clinical findings sometimes with the help of cardiac MRI (CMR). Investigators have previously shown that it was possible to give 50 % of the patients a diagnosis made by the combination of clinical findings and CMR made in median 12 days after the acute event. The present study aim at improve the diagnostic accuracy by an early CMR with latest technique.

Description:

The present study aim at improve the diagnostic accuracy in MINCA with an CMR made 2-4 days after the acute event. The aim is to give 70 % of all patients with MINCA (35-70 years old) a definitive diagnosis made by CMR only. One-hundred and fifty patients will be included and compared with a similar historical sample where 50 % of the patients received a diagnosis made by a late CMR and clinical findings. The study has 80 % power to detect this 20 % absolute difference (p <0.05).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 69 Years

Eligibility

Inclusion Criteria:

• 35-70 years

• Fullfill the diagnosic criteria of myocardial infarction

• Normal coronary angiography or minor atheromatosis

• Sinus rythm on ECG at admission

Exclusion Criteria:

• Previous myocardial infarction

• Known cardiomyopathy

• Pacemaker or claustrophobia

• Severe chronic obstructive lung or kidney disease

• Pulmonary embolism

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Procedure:
• CMR
Intervention performed 2-4 days after admission to hospital with the latest CMR technique including sensitive oedema sequences using T1 mapping

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Swedish Medical Research Council

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of an early CMR with the latest technique	Show that the more patients get a definite diagnosis (70%) when compared to a historical sample (50%)	2-4 days after admission
Secondary	Number of patients with correct diagnosis with echocardiography	To study the accuracy of echocardiography compared to CMR using ROC	12 months
Secondary	Number of patients with a postive CT angiography and infarction on CMR	To study CT angiography findings in relation to myocardial infarction shown by CMR	1 month
Secondary	Describe QoL over time		12 months