A Prospective, Single-center, Observational Study Aiming to Assess the Predictive Role of Flow Mediated Dilatation in Acute Coronary Syndromes, Combined With Echocardiographic and Biochemical Indices: The Novel Cor-IS Technology Will Also be Evaluated

NCT ID: NCT06890013

Last Updated: 2025-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2026-11-01

Brief Summary

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A prospective, single-center, observational study aiming to assess the predictive role of flow mediated dilatation in acute coronary syndromes, combined with echocardiographic and biochemical indices. The novel Cor-IS technology will also be evaluated.

Detailed Description

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Conditions

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Acute Coronary Syndromes Flow Mediated Dilation Endothelial Function (FMD)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observation group

Patients hospitalized due to acute coronary syndromes (STEMI, NSTEMI)

Observation group

Intervention Type DIAGNOSTIC_TEST

Patients with acute coronary syndrome undergo endothelial function assessment using two methods (flow mediated dilatation of the brachial artery and Cor-Is technology) transthoracic echocardiogram and plasma biomarkers' measurement.

Interventions

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Observation group

Patients with acute coronary syndrome undergo endothelial function assessment using two methods (flow mediated dilatation of the brachial artery and Cor-Is technology) transthoracic echocardiogram and plasma biomarkers' measurement.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Age \> 18 years
2. Patients hospitalized due to acute coronary syndrome (STEMI, NSTEMI)
3. Capability of providing written informed consent
4. Patients able to comply with the follow-up schedule of the study

Exclusion Criteria

1. Patients with acute coronary syndromes classified as MINOCA, or type II myocardial infarction
2. Patients with rare acute coronary syndrome types, such as spontaneous coronary artery dissection or Takotsubo syndrome
3. Patients with congenital heart disease
4. Age \> 85 years
5. Patients with end stage chronic kidney disease
6. Patients with active malignancy or autoimmune diseases which limit their survival
7. Patients with expected survival \< 1 year due to other reasons
8. Suboptimal echocardiographic windows
9. Inability to provide written consent
10. Inability to comply with the follow-up schedule of the study
11. Pregnancy
12. Use of intravenous drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christodoulos E. Papadopoulos, PhD

Role: PRINCIPAL_INVESTIGATOR

Aristotle University of Thessaloniki, Greece

Georgios Zormpas, MD

Role: PRINCIPAL_INVESTIGATOR

Aristotle University of Thessaloniki, Greece

Locations

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Ippokratio General Hospital

Thessaloniki, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Christodoulos E. Papadopoulos, PhD

Role: CONTACT

2313312343 ext. +30

Georgios Zormpas, MD

Role: CONTACT

2313312343 ext. +30

Facility Contacts

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Georgios Zormpas, MD

Role: primary

2313312343 ext. +30

Other Identifiers

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198/31.5.2024

Identifier Type: -

Identifier Source: org_study_id

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