Transit Time Flow Measurement in Coronary Surgery

NCT ID: NCT06471062

Last Updated: 2024-11-27

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

NOT_YET_RECRUITING

Total Enrollment

135 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-20

Study Completion Date

2025-10-20

Brief Summary

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Transit-time flowmetry (TTFM) allows grafts quality control during coronary artery bypass surgery by measuring the flow volume through them.

To date, many studies have deeply studied the predictive role on the graft outcomes of the various flowmetry-derived parameters. One of the least investigated aspects, however, is the mutual influence that two newly realized grafts can have. This possibility would be related to the presence of a more or less developed collateral circulation between the bypassed territories.

The purpose of this study is to assess whether a graft for a territory different than that provided by the left anterior descending artery (LAD) may affect the functionality (measured through flowmetry) of the left internal mammary artery - LAD graft.

Detailed Description

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Conditions

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Coronary Artery Disease Coronary Stenosis Coronary Bypass Graft Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* age \> 18 years;
* informed consent acquired and registered;
* patients who undergo coronary artery bypass grafting (with or without cardiopulmonary bypass);
* patients with stable angina, unstable angina or acute coronary syndrome without elevation of the ST tract (NSTEMI)

Exclusion Criteria

* patients unable to give informed consent;
* patients undergoing emergency surgery;
* patients in unstable haemodynamic conditions or in need of pharmacological or mechanical support;
* patients undergoing combined surgery;
* patients undergoing single aortocoronary bypass surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Federico Cammertoni

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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federico cammertoni

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Gemelli IRCCS

Locations

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Fondazione Policlinico Gemelli IRCCS

Roma, , Italy

Site Status

Countries

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Italy

Central Contacts

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cammertoni federico

Role: CONTACT

+393292060538

serena davino

Role: CONTACT

+393315618724

Facility Contacts

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cammertoni federico

Role: primary

+393292060538

serena d'avino

Role: backup

+393315618724

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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6646

Identifier Type: -

Identifier Source: org_study_id