## Protocol Section
### Identification Module
**NCT ID:** NCT06427512

**Brief Title:** Mechanisms Underlying Cardiovascular Consequences Associated With COVID-19 and Long COVID

**Official Title:** Mechanisms Underlying Cardiovascular Consequences Associated With COVID-19 and Long COVID - Characterizing Long COVID Phenotypes Using Physiological and Molecular Studies

#### Organization Study ID Info
**ID:** AAA-TBA
#### Organization
**Class:** OTHER
**Full Name:** Columbia University
### Status Module
#### Completion Date
**Date:** 2025-03

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** WITHDRAWN

#### Primary Completion Date
**Date:** 2025-03

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-03

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2022-02-01
**Study First Submit QC Date:** 2024-05-20
**Why Stopped:** Funding not available
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** American Heart Association

#### Lead Sponsor

**Class:** OTHER

**Name:** Columbia University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** AIM 1. Characterize cardiovascular phenotypes of long COVID by cardiopulmonary, meta-bolic, and cardiac mechanical/physiological responses to exercise and microvascular vasomotor function.

AIM 2. Identify intercellular signaling between immune cells and cardiac cells associated with microvascular phenotypes of long COVID.

**Detailed Description:** As many as 40-60% of patients who recovered from mild or moderate acute COVID have reported what is now called long COVID - multiple, persistent or recurrent symptoms lasting 6-9 months (or longer) following initial illness.1-4 Fatigue, dyspnea, and chest pain are the most common symptoms. Others include palpitations, lightheadedness, and syncope. All these cardiovascular symptoms can be debilitating, resulting in worse quality of life and morbidity.5, 6 Treatment options are limited.

### Conditions Module

**Conditions:**

- COVID-19

**Keywords:**

- long COVID-19

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients with long COVID-19 and experiencing cardiovascular symptoms at 24 weeks post-acute illness or post-COVID without cardiovascular symptoms by 8 weeks after illness.

**Label:** COVID patients

### Outcomes Module

#### Primary Outcomes

**Description:** This is to measure the microvascular dysfunction in patients using Cardiac PET.

**Measure:** Prevalence of Microvascular dysfunction

**Time Frame:** Up to 2.5 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age \> 18, \< 75 yrs
* History of lab-confirmed COVID
* Symptomatic at \>12 wks post-acute COVID (cases)
* Recovered by 8wks post-acute COVID (controls)

Exclusion Criteria:

* Any history of critical illness
* Chronic kidney disease, Stage \>4
* Pre-COVID: HFrEF, CABG, arrhythmia; pulmonary hypertension, pulmonary embolus, interstitial lung disease (ILD), O2 dependence; dementia, stroke, autonomic dysfunction; coagulopathy
* Post-COVID: ILD, O2 dependence

**Maximum Age:** 74 Years

**Minimum Age:** 19 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** The study population will be recruited primarily from the Prospective COVID-19 ID Persistence Cohort (C-PIC).

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** New York

**Country:** United States

**Facility:** CUIMC

**State:** New York

**Zip:** 10032

#### Overall Officials

**Official 1:**

**Affiliation:** Florence Irving Associate Professor of Medicine, Dept of Medicine Cardiology

**Name:** Emily Tsai, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Blomberg B, Mohn KG, Brokstad KA, Zhou F, Linchausen DW, Hansen BA, Lartey S, Onyango TB, Kuwelker K, Saevik M, Bartsch H, Tondel C, Kittang BR; Bergen COVID-19 Research Group; Cox RJ, Langeland N. Long COVID in a prospective cohort of home-isolated patients. Nat Med. 2021 Sep;27(9):1607-1613. doi: 10.1038/s41591-021-01433-3. Epub 2021 Jun 23.

**PMID:** 34163090

**Citation:** Nehme M, Braillard O, Alcoba G, Aebischer Perone S, Courvoisier D, Chappuis F, Guessous I; COVICARE TEAM. COVID-19 Symptoms: Longitudinal Evolution and Persistence in Outpatient Settings. Ann Intern Med. 2021 May;174(5):723-725. doi: 10.7326/M20-5926. Epub 2020 Dec 8. No abstract available.

**PMID:** 33284676

**Citation:** Nehme M, Braillard O, Chappuis F, Courvoisier DS, Guessous I; CoviCare Study Team. Prevalence of Symptoms More Than Seven Months After Diagnosis of Symptomatic COVID-19 in an Outpatient Setting. Ann Intern Med. 2021 Sep;174(9):1252-1260. doi: 10.7326/M21-0878. Epub 2021 Jul 6.

**PMID:** 34224254

**Citation:** Soriano JB, Murthy S, Marshall JC, Relan P, Diaz JV; WHO Clinical Case Definition Working Group on Post-COVID-19 Condition. A clinical case definition of post-COVID-19 condition by a Delphi consensus. Lancet Infect Dis. 2022 Apr;22(4):e102-e107. doi: 10.1016/S1473-3099(21)00703-9. Epub 2021 Dec 21.

**PMID:** 34951953

**Citation:** Huang L, Yao Q, Gu X, Wang Q, Ren L, Wang Y, Hu P, Guo L, Liu M, Xu J, Zhang X, Qu Y, Fan Y, Li X, Li C, Yu T, Xia J, Wei M, Chen L, Li Y, Xiao F, Liu D, Wang J, Wang X, Cao B. 1-year outcomes in hospital survivors with COVID-19: a longitudinal cohort study. Lancet. 2021 Aug 28;398(10302):747-758. doi: 10.1016/S0140-6736(21)01755-4. Erratum In: Lancet. 2022 May 7;399(10337):1778.

**PMID:** 34454673

**Citation:** Sigfrid L, Drake TM, Pauley E, Jesudason EC, Olliaro P, Lim WS, Gillesen A, Berry C, Lowe DJ, McPeake J, Lone N, Munblit D, Cevik M, Casey A, Bannister P, Russell CD, Goodwin L, Ho A, Turtle L, O'Hara ME, Hastie C, Donohue C, Spencer RG, Donegan C, Gummery A, Harrison J, Hardwick HE, Hastie CE, Carson G, Merson L, Baillie JK, Openshaw P, Harrison EM, Docherty AB, Semple MG, Scott JT; ISARIC4C investigators. Long Covid in adults discharged from UK hospitals after Covid-19: A prospective, multicentre cohort study using the ISARIC WHO Clinical Characterisation Protocol. Lancet Reg Health Eur. 2021 Sep;8:100186. doi: 10.1016/j.lanepe.2021.100186. Epub 2021 Aug 6.

**PMID:** 34386785

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011024

- Term: Pneumonia, Viral

- ID: D000011014

- Term: Pneumonia

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000018352

- Term: Coronavirus Infections

- ID: D000003333

- Term: Coronaviridae Infections

- ID: D000030341

- Term: Nidovirales Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000094025

- Term: Post-Infectious Disorders

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M3013

- Name: Post-Acute COVID-19 Syndrome

- Relevance: HIGH

- As Found: Long COVID

- ID: M2561

- Name: COVID-19

- Relevance: HIGH

- As Found: COVID-19

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M13904

- Name: Pneumonia

- Relevance: LOW

- As Found: Unknown

- ID: M13914

- Name: Pneumonia, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20490

- Name: Coronavirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6555

- Name: Coronaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M23685

- Name: Nidovirales Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3014

- Name: Post-Infectious Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000086382

- Term: COVID-19

- ID: D000094024

- Term: Post-Acute COVID-19 Syndrome

### Misc Info Module

- Version Holder: 2024-05-31
