NCT04724707

Brief Summary

This is a Russian multicenter observational study aimed to assess the mid-term and long-term prognosis in patients recovered from COVID-19 with the involvement of the cardiovascular system or with baseline severe cardiovascular diseases.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 11, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 26, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

1.2 years

First QC Date

January 16, 2021

Last Update Submit

January 25, 2021

Conditions

Covid19Acute Cardiovascular DiseaseCardiovascular Diseases

Keywords

SARS-CoV-2Covid19Cardiovascular disease

Outcome Measures

Primary Outcomes (4)

  • Death

    Number of patients died during the follow up

    12 months

  • Hospitalization for cardiovascular reasons

    Number of patients hospitalized for cardiovascular reasons during the follow up

    12 months

  • Hospitalization for any reason

    Number of patients hospitalized for any reason during the follow up

    12 months

  • Time to death

    Number of days to death

    12 months

Secondary Outcomes (6)

  • Mechanical support or heart transplant

    12 months

  • ICD or CRT

    12 months

  • Quality of life

    12 months

  • Cardiac pacing or catheter ablation

    12 months

  • Syncope or presyncope

    12 months

  • +1 more secondary outcomes

Study Arms (5)

Myocarditis

Proven or suspected myocarditis

Heart failure

Heart failure (NYHA functional class II-IV) before or during hospitalization with COVID-19

ACS

Combination of COVID-19 with ACS or development of ACS during hospitalization with COVID-19 or performed percutaneous coronary intervention

Pulmonary embolism

Proven pulmonary embolism

Arrhythmias

Hemodynamically significant arrhythmias (atrial fibrillation, high-grade ventricular premature beats, paroxysmal ventricular arrhythmias), including those associated with the QT interval prolongation

Eligibility Criteria

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

The study population are the patients recovered from COVID-19 with the involvement of the cardiovascular system or with baseline severe cardiovascular diseases.

You may qualify if:

  • Age ≥18 years of age
  • Hospitalization with confirmed or suspected COVID-19 (ICD-10 codes U07.1 or U07.2)
  • Involvement of the cardiovascular system or baseline severe cardiovascular diseases defined as at least of the following:
  • proven or suspected myocarditis;
  • heart failure (NYHA functional class II-IV) before or during hospitalization with COVID-19;
  • combination of COVID-19 with ACS or development of ACS during hospitalization with COVID-19 or performed percutaneous coronary intervention;
  • proven pulmonary embolism;
  • hemodynamically significant arrhythmias (atrial fibrillation, high-grade ventricular premature beats, paroxysmal ventricular arrhythmias), including those associated with the QT interval prolongation

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Almazov National Medical Research Centre

Saint Petersburg, 197341, Russia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples for biochemistry, coagulation and genetic tests

MeSH Terms

Conditions

COVID-19Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2021

First Posted

January 26, 2021

Study Start

September 11, 2020

Primary Completion

December 1, 2021

Study Completion

December 1, 2022

Last Updated

January 26, 2021

Record last verified: 2021-01

Locations

RU(1)