NCT05960474

Brief Summary

The purpose of this project is to provide appropriate administrative and technical supports for the warehousing and use of a database of patients with coronary microvascular disease (CMD). This protocol will outline the process for identification and capture of data, storage, as well as data use and sharing internally and externally for research purposes.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
81mo left

Started Feb 2023

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

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 Progress33%
Feb 2023Jan 2033

Study Start

First participant enrolled

February 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 25, 2023

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2033

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2033

Last Updated

June 7, 2024

Status Verified

June 1, 2024

Enrollment Period

9.9 years

First QC Date

July 17, 2023

Last Update Submit

June 6, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Establish a Registry of CMD patients

    10 years

Interventions

Our objective is to perform a retrospective/prospective descriptive study on the short term to longterm (up to 5 years of follow-up) outcomes of patients with coronary microvascular disease diagnosis invasively

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects to be enrolled in either objective for this registry includes patients, 18 years or older, with coronary microvascular disease.

You may qualify if:

  • Those with Coronary Microvascular Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Memorial Regional Hospital

Hollywood, Florida, 33021, United States

RECRUITING

MedStar Southern Maryland

Clinton, Maryland, 20735, United States

RECRUITING

Related Publications (7)

  • Al Qaraghuli A, Chitturi KR, Kumar S, Cellamare M, Ozturk S, Sawant V, Zhang C, Verma BR, Galo J, Chaturvedi A, Ben-Dor I, Satler L, Rogers T, Waksman R, Hashim H, Case BC. Exploring the impact of age on microvascular function: Insights from the Coronary Microvascular Disease Registry. Int J Cardiol. 2026 Jan 1;442:133858. doi: 10.1016/j.ijcard.2025.133858. Epub 2025 Sep 2.

  • Abusnina W, Merdler I, Cellamare M, Chitturi KR, Chaturvedi A, Feuerstein IM, Zhang C, Ozturk ST, Deksissa T, Sawant V, Lopez K, Lupu L, Haberman D, Ben-Dor I, Satler LF, Waksman R, Hashim HD, Case BC. Epicardial Fat Tissue: A Potential Marker for Coronary Microvascular Dysfunction. J Am Heart Assoc. 2025 Feb 4;14(3):e038484. doi: 10.1161/JAHA.124.038484. Epub 2025 Feb 3.

  • Chitturi KR, Kumar S, Frisancho FT, Rahman S, Verma BR, Cellamare M, Merdler I, Ozturk ST, Cermak V, Sawant V, Zhang C, Ben-Dor I, Waksman R, Hashim HD, Case BC. The Prevalence of Coronary Microvascular Dysfunction in Patients With Type 2 Diabetes Mellitus. Catheter Cardiovasc Interv. 2025 Apr;105(5):1120-1123. doi: 10.1002/ccd.31429. Epub 2025 Jan 29.

  • Chitturi KR, Kumar S, Hill AP, Lorente-Ros M, Cellamare M, Merdler I, Abusnina W, Haberman D, Lupu L, Chaturvedi A, Ozturk ST, Cermak V, Sawant V, Zhang C, Ben-Dor I, Tsimploulis A, Waksman R, Hashim HD, Case BC. Prevalence of Arrhythmias in Patients With Coronary Microvascular Dysfunction. Catheter Cardiovasc Interv. 2025 Feb;105(2):483-490. doi: 10.1002/ccd.31324. Epub 2024 Dec 11.

  • Merdler I, Bazarbashi N, Medranda GA, Zhang C, Ozturk ST, Sawant V, Ben-Dor I, Waksman R, Hashim HD, Case BC. Comparing planned versus ad hoc coronary microvascular assessment: Early findings from the Coronary Microvascular Disease Registry. Cardiovasc Revasc Med. 2024 Oct;67:69-74. doi: 10.1016/j.carrev.2024.04.017. Epub 2024 Apr 12.

  • Case BC, Merdler I, Medranda GA, Zhang C, Ozturk ST, Sawant V, Garcia-Garcia HM, Satler LF, Ben-Dor I, Hashim HD, Waksman R. Coronary Microvascular Disease Registry (CMDR): Study design and rationale. Cardiovasc Revasc Med. 2024 Sep;66:63-67. doi: 10.1016/j.carrev.2024.03.021. Epub 2024 Mar 27.

  • Merdler I, Wallace R, Banerjee A, Medranda GA, Reddy P, Cellamare M, Zhang C, Ozturk ST, Sawant V, Lopez K, Ben-Dor I, Waksman R, Case BC, Hashim HD. Coronary microvascular dysfunction assessment: A comparative analysis of procedural aspects. Catheter Cardiovasc Interv. 2024 Apr;103(5):703-709. doi: 10.1002/ccd.30990. Epub 2024 Mar 23.

MeSH Terms

Interventions

Treatment Outcome

Intervention Hierarchy (Ancestors)

PrognosisDiagnosisOutcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationHealth Care Evaluation MechanismsHealth Care Quality, Access, and Evaluation

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2023

First Posted

July 25, 2023

Study Start

February 1, 2023

Primary Completion (Estimated)

January 1, 2033

Study Completion (Estimated)

January 1, 2033

Last Updated

June 7, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations