NCT03364387

Brief Summary

The objective of this study is to analyze the Demographics, Clinical Profiles, Management, in-Hospital and Long-Term Outcomes of Patients with Acute Coronary Syndrome Syndrome And Myocardial Infarction with Non-obstructive Coronary Artery Disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16,026

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 6, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

March 5, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2018

Completed
Last Updated

July 24, 2018

Status Verified

July 1, 2018

Enrollment Period

2 months

First QC Date

November 30, 2017

Last Update Submit

July 23, 2018

Conditions

Keywords

Acute Coronary SyndromeMINOCAMyocardial InfarctionAtrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Composites of Myocardial Infarction, Hospitalization, Revascularization, Death

    Re-infarction, Any cause or Cardiovascular Hospitalization or Death

    12 months

Secondary Outcomes (2)

  • Atrial Fibrillation

    12 months

  • Heart failure

    12 months

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Study population will consisted patients with acute coronary syndrome undergoing invasive diagnostic coronary angiography. Patients will eligible to take part in the study if they will fulfilled the criteria for acute myocardial infarction.

You may qualify if:

  • Patients older than 18 years
  • Evidence of an MI as defined any one of the following criteria:
  • Detection of a rise and/or fall of cardiac biomarker values \[preferably cardiac troponin (cTn)\] with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following:
  • i. Symptoms of ischaemia. ii. New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundle branch block (LBBB).
  • iii. Development of pathological Q waves in the ECG. iv. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
  • v. Identification of an intracoronary thrombus by angiography.
  • Invasive diagnostic coronary angiography (IDCA) findings to allow determination of the presence /absence of obstructive coronary artery disease
  • Signed informed consent form to trial participation

You may not qualify if:

  • Inability/Refused to provide informed consent
  • Age below 18 years
  • Patients with unstable angina pectoris (ACS without increase and/or decrease of a cardiac biomarker, preferably high-sensitivity cardiac troponin, with at least one value above the 99th percentile of the upper reference limit)
  • Patients refused invasive diagnostic coronary angiography
  • Myocardial infarction associated with revascularization procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emin Alioğlu

Izmir, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fasting venous blood sample

MeSH Terms

Conditions

Acute Coronary SyndromeMyocardial InfarctionAtrial FibrillationDiabetes MellitusMINOCA

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisArrhythmias, CardiacGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2017

First Posted

December 6, 2017

Study Start

March 5, 2018

Primary Completion

May 15, 2018

Study Completion

June 15, 2018

Last Updated

July 24, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations