Southeastern Europe Microcirculation Registry (SATURATION)

May 12, 2024 updated by: Ivan Ilić, MD, PhD, Institute for Cardiovascular Diseases "Dedinje"
SATURATION is a prospective multicenter registry of consecutive patients who undergo coronary physiology testing using Pressure Wire X and Coroflow Coroventis Cardiovascular System software (Abbott Vascular, Abbott Park, IL, USA) and to assess the regional practice of patient selection, cardiovascular outcomes and additional procedures (stress testing, angiography, etc.) done after comprehensive invasive coronary physiology evaluation.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The study will include adults of both sexes older than 18 years with angina symptoms or angina equivalent referred to cath lab for evaluation of coronary artery disease (CAD) that underwent invasive physiology testing performed (microcirculation testing +/- vasospasm testing) using Coroflow Coroventis Cardiovascular system (Abbott Vascular, Abbott Park, IL, USA) The study will exclude persons under the age of 18, pregnant of nursing ant the ones where no coronary physiology measurements performed

.

The following data will be collected at enrollment:

  • De-identified demographic data
  • Cardiovascular risk factors and significant co-morbidities
  • Laboratory investigations of interest
  • Prior cardiovascular events
  • Pre-procedure medications
  • Echocardiogram within 3 months of invasive coronary procedure
  • Non-invasive ischemia testing within 3 months of invasive coronary procedure
  • Seattle Angina Questionnaire (SAQ)
  • EQ-5D-5L
  • Details of the coronary angiography and invasive physiology procedure including procedural complications
  • Post-procedure medications

Data that will be collected during invasive coronary physiology testing:

Vasospastic angina testing (which artery, what test, result) Microvascular angina testing (which artery, CFR, IMR, RRR, FFR, Pd, Pa and all transit times)

Patients will be seen at follow up visits and the following data will be collected every 6 months for up to 5 years:

  • Major adverse cardiovascular events including repeat invasive coronary angiography since last follow up
  • Current medications
  • SAQ
  • EQ-5D-5L
  • Non-invasive ischemia testing since last follow up Outcomes will be evaluated every 6 months for 5 years via direct patient contact by research staff or at follow up visits. Outcomes will be collected based on existing medical documentation.

Primary outcomes:

  • all-cause death and non-fatal MI
  • composite MACE: all-cause death, non-fatal MI, coronary revascularization, hospitalization for cardiovascular causes (acute coronary syndrome, heart failure, angina, repeated coronary angiography) Secondary outcomes: all-cause death, cardiovascular death, MI, coronary revascularization, stroke, hospitalization for heart failure, hospitalization for acute coronary syndrome, repeated coronary angiography

Patient-centered outcomes:

  • Freedom from angina (SAQ questionnaire)
  • Quality of life using EQ-5D-5L questionnaire
  • Follow up non-invasive ischemia testing (if performed)

Study Type

Observational

Enrollment (Estimated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients suffering from angina who undergo coronary physiology testing using Pressure Wire X and Coroflow Coroventis Cardiovascular System software (Abbott Vascular, Abbott Park, IL, USA).

Description

Inclusion Criteria:

  • Adults of both sexes older than 18 years
  • Angina symptoms or angina equivalent
  • Referred to Cath lab for evaluation of CAD
  • Invasive physiology testing performed (microcirculation testing +/- vasospasm testing) using Coroflow Coroventis Cardiovascular system (Abbott Vascular, Abbott Park, IL, USA)

Exclusion Criteria:

  • Persons under the age of 18
  • Pregnant of nursing
  • No coronary physiology measurements performed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all-cause death and non-fatal MI
Time Frame: 5 years
The study will record aggregate number of participants that died and/or suffered from myocardial infarction after invasive physiology procedure
5 years
composite MACE
Time Frame: 5 years
The study will record aggregate number of participants that died from any cause and/or experienced non-fatal myocardial infarction and/or coronary angioplasty procedure and/or hospitalization for cardiovascular causes (acute coronary syndrome, heart failure, angina, repeated coronary angiography)
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all-cause death
Time Frame: 5 years
The study will record number of participants that died after invasive coronary physiology
5 years
cardiovascular death
Time Frame: 5 years
The study will record number of participants that died due to cardiovascular causes after invasive coronary physiology
5 years
myocardial infarction
Time Frame: 5 years
The study will record the number of participants that suffered from myocardial infarction after invasive coronary physiology
5 years
coronary revascularization
Time Frame: 5 years
The study will record number of participants that undergo surgical and/or percutaneous revascularization after invasive coronary physiology
5 years
stroke
Time Frame: 5 years
The study will record the number of participants that suffered from stroke after invasive coronary physiology
5 years
hospitalization for heart failure
Time Frame: 5 years
The study will record the number of participants that are hospitalized for heart failure after invasive coronary physiology
5 years
hospitalization for acute coronary syndrome
Time Frame: 5 years
The study will record the number of participants that are hospitalized for acute coronary syndrome after invasive coronary physiology
5 years
repeated coronary angiography
Time Frame: 5 years
The study will record the number of participants that undergo repeated coronary angiography after invasive coronary physiology
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute for Cardiovascular Diseases "Dedinje"

Collaborators

Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2034

Study Registration Dates

First Submitted

April 26, 2024

First Submitted That Met QC Criteria

April 26, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 12, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IKVBD-KARD-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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